Sökresultat för "Pharmaceutical Development"

Vill du arbeta nära forskning och utveckling av framtidens läkemedelsprodukter? Vi söker nu en analytisk kemist eller laboratorietekniker som vill bidra med sin kompetens inom fysikalisk karakterisering och vara en viktig del av vårt utvecklingsteam. I rollen arbetar du med att analysera och förstå fysikaliska och kemiska egenskaper hos pulver, suspensioner och injicerbara formuleringar. Du kombinerar praktiskt laboratoriearbete med metodutveckling, datagranskning och samarbete med kollegor inom formulering, analys och projektledning. Hos oss får du arbeta i en utvecklingsmiljö där dina analyser bidrar till viktiga beslut i prekliniska och tidiga kliniska projekt. Rollen passar dig som trivs i laboratoriet, uppskattar noggrant och strukturerat arbete och samtidigt vill vara med och utveckla metoder, arbetssätt och processer. Exempel på arbetsuppgifter Du kommer bland annat att: Utföra fysikalisk och kemisk karakterisering av råvaror, mellanprodukter och färdiga formuleringar. Arbeta med tekniker såsom laserdiffraktion, BET, Karl Fischer, elektronmikroskopi, viskositetsmätning, TGA och HPLC. Delta i metodutveckling, metodvalidering och förbättringsarbete. Planera, genomföra och dokumentera experiment samt sammanställa resultat i rapporter. Granska data och säkerställa att analyser genomförs enligt gällande kvalitetskrav. Bidra till stabilitetsstudier och tvärfunktionella utvecklingsprojekt. Delta i den dagliga driften av laboratoriet, inklusive instrumentvård och underhåll. Vi söker dig som gillar att kombinera noggrannhet och struktur med nyfikenhet och problemlösning. Du trivs med laborativt arbete och har ett naturligt fokus på kvalitet i allt du gör. Samtidigt tycker du om att samarbeta med andra, dela kunskap och bidra till att utveckla både metoder och arbetssätt. Oavsett om det handlar om rutinmässiga analyser eller nya utmaningar drivs du av att leverera tillförlitliga resultat som bidrar till att föra projekten framåt. För rollen ser vi också att du: Har en akademisk utbildning inom analytisk kemi, fysikalisk kemi, materialkemi, farmaceutisk vetenskap eller motsvarande. Har erfarenhet av laborativt analytiskt arbete. Har mycket goda kunskaper i engelska och kan kommunicera väl i både tal och skrift. Har goda kunskaper i svenska. Det är även meriterande om du har Erfarenhet av fysikalisk karakterisering. Vana att arbeta enligt etablerade analysmetoder och instruktioner. Erfarenhet från GMP-reglerad verksamhet eller andra kvalitetssystem. Praktisk erfarenhet av flera av de analystekniker som används i rollen. Om Nanexa Nanexa är ett innovativt läkemedelsbolag med bas i Uppsala som utvecklar framtidens depåläkemedel. Genom vår unika PharmaShell®-teknologi kombinerar vi avancerad materialvetenskap med läkemedelsutveckling för att skapa nya behandlingsmöjligheter inom flera terapiområden. Hos oss blir du en del av ett engagerat team där vetenskaplig nyfikenhet, kvalitet och samarbete driver utvecklingen framåt. Vår kultur På Nanexa bygger vi vår kultur på tre värderingar – att vara stöttande, målinriktade och kreativa. För oss innebär det att vi hjälper varandra att lyckas, arbetar fokuserat mot gemensamma mål och vågar tänka nytt för att hitta lösningar på komplexa utmaningar. Vi kombinerar vetenskaplig noggrannhet med nyfikenhet och entreprenörsanda, och tror att de bästa resultaten skapas när människor samarbetar, delar kunskap och utvecklas tillsammans. Ansökan Låter detta som en roll för dig? Varmt välkommen med din ansökan på rekrytering@nanexa.se senast den 30/8. Märk din ansökan med Fysikalisk. Urval och intervjuer sker löpande, så skicka gärna in din ansökan så snart som möjligt. Har du frågor om tjänsten är du välkommen att kontakta Joel Hellrup, Head of Pharmaceutical R&D, på +46 (0) 70 972 27 45 eller joel.hellrup@nanexa.se. För frågor om rekryteringsprocessen är du välkommen att kontakta Therese Näs, HR, på Therese.nas@Nanexa.se Läs gärna mer om Nanexa på vår hemsida www.nanexa.se

Professional Galaxy is an IT and technology consulting company that provides highly specialized expertise within IT, software development, SAP, purchasing, electronics and mechanical design. We collaborate with experienced senior experts and deliver strategic value-creating expertise to some of Sweden's most complex and analytically demanding projects. Our focus is always on high quality, professionalism and clear, measurable results. We are now seeking a Supply Chain Manager for Clinical Trial medications for one of our clients. About the assignment: Would you like to utilize your planning and supply chain knowledge to lead clinical supplies for your portfolio of global clinical studies? With constant new products and launches, there has never been a better time to join Global Clinical Supply Chain and shape our future with a significant contribution to life-changing medicines. We have an exciting opportunity for talented Supply Chain Managers to join our Clinical Study Supply Chain team in Gothenburg, Sweden. This is a key role within our Clinical Manufacturing and Supply teams, and we make sure clinical trial medications are available at the right quality, in the right quantity at the right time for every patient taking part in xx trials all over the world. Our goal is to never miss a patient. In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Tasks and responsibilities/The role: In this role you will project manage the design, plan, and set-up of the study supply chain to ensure on time delivery of clinical supplies. You will also lead a cross-functional team enabling continuous dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study. To be successful in this role you need to be a fast learner, self-driven and comfortable working in a high pace R&D environment. You need to be a collaborative team player, flexible and have strong communication, planning and problem-solving skills. Your main responsibilities will include: • Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply. • Ensure effective communication with project teams and key partners across a global network. • Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies. • Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction. • Manage the Interactive Response Technology (IRT) system to execute demand and supply planning. • Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls. Soft skills: • Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries • Ability to adapt and operate in bespoke multiple systems. Desirable for the role: • Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice) • Knowledge of clinical development processes relevant to the supply of clinical materials • Lean knowledge and understanding • Experienced in handling Quality Events (Deviations, Change Controls, Complaints Location: Göteborg Start date: 2026-06-01 End date: 2027-05-31 Application Deadline: 2026-04-19 Are you the right person for the assignment, or do you want to recommend a strong candidate? Do not hesitate to contact us. Please apply directly through our system with: - Your updated CV in english - Availability to start the assignment In the motivation, describe why you are suitable for this assignment - refer to previous consulting assignments, employmxent, education and personal qualities. Please note: We do not accept any applications through mail. All applications have to be sent through the portal to be valid. Offer continuously: Please note that for this role we offer continuously. That means that we sometimes remove the assignments before the deadline. If you are interested, we recommend that you apply immediately.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. The Executive Administrator performs and oversees all administrative related and selected operational services for the Global Head, Business Development ("GBDH"). Position requires broad understanding of corporate operations and policies. A high level of administrative and operational support and advanced computer technology experience is required. Ability to multi-task is essential. Must operate with discretion with internal and external executives and stakeholders, and exercise independent judgment and initiative.  Key Responsibilities:   * Works directly with C-level executives and other senior leaders; serves as a liaison for the Executive Committee and the Board of Directors as needed for GBD-related topics performing a wide range of administrative duties of a highly responsible and confidential nature. * Collaborate closely with other administrators, business leaders and global colleagues. * Support GBD with organizing and planning complex face-to-face and virtual internal and external / partner meetings and conferences across multiple time zones and demonstrate flexibility in work schedule to participate in these meetings. * Attend GBD Leadership Team ("GBD LT") meetings, prepare and maintain meeting notes. Manage data and prepare / support preparation of presentations as needed. * Exhibit a positive work attitude, high productivity and a collaborative approach with employees across an international environment. * Compose correspondence on behalf of GBDH from minimal information or written draft, utilizing tactful command of proper business writing and grammar; proof-read documents and presentations. * Coordinate and utilize travel procedures to complete domestic and international travel, process travel and expense reimbursement in a timely manner. * Comply with policies and procedures and manage the purchase order and requisition process related to supporting duties. * Suggest and drive improvement processes when applicable. * Support additional ad hoc assignments as requested   Qualifications: Education * A High School Diploma or GED required. * Business school, associate's degree or equivalent is a plus. Experience * A minimum of 8 years in a corporate environment; with pharmaceutical experience preferred. Technical Skills * Manage documents effectively from and to various software programs demonstrating a comfort level with various technologies and quickly learn technologies as necessary. * Proficient in MS Office Suite (MS Word, Excel, PowerPoint), Travel and Expense systems (e.g., Concur), and other relevant software. Non-Technical Skills * Executive-level communication skills (verbal and written); high discretion and professionalism in handling confidential matters; strong interpersonal skills and stakeholder relationship management. * Advanced organizational and multitasking capabilities; exceptional attention to detail and accuracy; effective prioritization and deadline management; sound judgment and decision-making ability. * Strong problem-solving skills and adaptability in ambiguous situations; flexibility and resilience in fast-paced, high-growth environments; proven ability to influence, collaborate, and drive consensus across global, multicultural teams. * Strong work ethic with accountability and consistent follow-through; proactive mindset with commitment to continuous learning and development The anticipated salary for this position will be $83,000 to $105,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs. Essential Functions: •    Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value. •    Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture. •    Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders. •    Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects. •    Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution. •    Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables. •    Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution. •    Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes. •    Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate. •    Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs. •    Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions. •    Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization. •    Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements. •    Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives. •    Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function. •    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision. Requirements: Education Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required.  Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education. Experience •    Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.  •    Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs) •    Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval) •    Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations •    Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations •    Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D. Technical Skills •    Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management •    Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations •    Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS) •    Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions •    Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness •    Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance •    Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously. •    Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making. •    Strong proficiency MS Office Suite. Working Conditions: Requires up to domestic and international travel. The anticipated salary for this position will be $265,000-$285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

We are looking for a driven Line Controller / Business Controller with around 5 years of experience to join an international biopharmaceutical company experiencing strong growth. This is a perfect opportunity for a controller who is ready for a natural next step in their career, combining hands-on line controlling with finance business partnering in a complex global organization. We review applications continuously, so do not hesitate to apply today! About the role Our client is looking for a dedicated Line Controller to take on a central and business-facing role within Research, Development and Medical Affairs (RDMA). The organization manages an annual budget of several billion SEK, divided between project activities and the ongoing line organization, comprising approximately 200 employees and 100 cost centers across Europe, the US, and Japan. In this role, you will act as a financial business partner to several functional line leaders, translating business plans into financial realities and creating transparency around performance. This is a dynamic role suited for someone who wants to combine qualified finance business partnering with clear operational line responsibility (budgeting, forecasting, cost center management, and variance analysis) in a global environment. You are offered A natural career step: A role where you get full ownership of your areas and room to grow in a global biopharmaceutical environment. A strong international network: Collaborate closely with global functional leaders, international co-controllers, and an experienced finance team. Strategic and operational variety: A highly varied role where you move seamlessly between forecasting discussions with functional leaders and hands-on Excel analysis, cost center management, and follow-ups Work tasks Your responsibilities will include: Act as a financial business partner to functional leaders and senior stakeholders within RDMA. Develop a thorough understanding of business plans, priorities, resource requirements, and cost drivers. Constructively challenge budget owners' assumptions and plans, helping to identify practical solutions that balance scientific needs with available resources. Drive the four annual planning and forecasting cycles, including the budget process. Coordinate and quality-assure financial input from a large number of cost centers and business areas. Monitor actual performance against budget/forecast and analyze the underlying causes of variances. Identify financial risks and opportunities, explaining their impact on the full-year forecast. Take ownership of relevant month-end and quarter-end close activities (accruals, reallocations, and closing documentation). Collaborate with accounting, Business Controllers, System Controllers, and the wider global finance organization to improve processes and transparency. We are looking for Around 4-6 years of relevant experience in Business Controlling, Line Controlling, or Finance Business Partnering. Experience with budgeting, forecasting, financial planning, and performance management. Have a solid understanding of month-end closing, accruals, and other accounting-related controlling activities. Have strong analytical capabilities and advanced Excel skills. Are fluent in English and have good communication skills in Swedish. It is meritorious if you have Are fluent in Swedish. Experience in the life science pharmaceutical, research, or other knowledge-intensive industries. Experience in R&D controlling. Experience in providing financial support and guidance to teams or organizations working with clinical studies. Experience with large ERP systems, financial reporting tools, or digital/AI-enabled automation in finance. To succeed in the role, your personal skills are: Structured Proactive Driven Communicative team payer Social Our recruitment process This recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work. Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The Associate Director, Scientific Communications, Rare Disease is responsible for supporting the development, execution, and continuous optimization of scientific communications initiatives for the Rare Disease Medical Affairs organization in North America. The role leads the planning, development, review, and implementation of scientific materials and educational programs that support Medical Affairs strategic objectives and ensure the accurate, balanced, and compliant dissemination of scientific information. Core focus of the role includes overseeing the development and lifecycle management of Field Medical materials; creating scientific content and supporting the execution of Medical Advisory Boards, Scientific Symposia, Medical Education initiatives, and conference-related deliverables; and managing external Medical Communications agencies and Medical Education partners to ensure the timely delivery of high-quality, scientifically accurate materials. The Associate Director collaborates cross-functionally with Medical Affairs and other internal stakeholders to ensure scientific communications activities are aligned with organizational priorities and compliant with applicable policies and regulatory requirements. Essential Functions: * Support data disclosure and scientific dissemination activities associated with clinical trial milestones and major medical congresses for U.S. Medical Affairs. * Provide content and editorial support for regional publications and scientific presentations. * Ensure regional publication priorities are represented in the global publication plan and support localization of global publication activities to meet regional needs. * Collaborate with global and regional Medical Affairs teams to ensure consistency of scientific messaging and alignment with regional medical strategy. * Partner with external medical communications agencies and vendors to manage the quality, timelines, and budgets of scientific communications deliverables. * Support external expert engagement and steering committee activities, including coordination of content review and approval workflows. * Support scientific and medical operations, including advisory board planning and execution, medical information initiatives, and Medical Science Liaison (MSL) training. * Represent Medical Affairs at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, as needed, ensuring materials are scientifically accurate, current, appropriately substantiated, and properly referenced. * Ensure all scientific communications activities are conducted in compliance with applicable SOPs, policies, regulatory requirements, ICMJE recommendations, Good Publication Practice (GPP) guidelines, and company compliance standards. * Perform additional duties and special projects as assigned. Job Requirements: Education Advanced degrees in life sciences, health sciences, pharmacy, medicine, nursing, or a related scientific discipline (MD, PharmD, PhD, DNP, or equivalent) required.  Experience * Minimum of seven (7) years in the pharmaceutical, biotechnology, or medical communications industry within Medical Affairs or Scientific Communications. * Minimum of three (3) years supporting Scientific Communications, Publications, or Medical Communications functions. * Demonstrated success developing and executing scientific communication initiatives, including field medical materials, advisory boards, scientific symposia, medical education programs, publications, and congress deliverables. * Proven ability to collaborate with cross-functional stakeholders and manage external medical communications agencies and vendors to deliver high-quality scientific materials. * Background supporting publication planning, scientific dissemination, and data disclosure activities associated with clinical development and medical congresses. * Familiarity with medical, promotional, and publication review processes within a regulated pharmaceutical or biotechnology environment. * Rare Disease experience is strongly preferred. Technical Skills * Working knowledge of scientific communications, publication planning, Good Publication Practice (GPP) guidelines, International Committee of Medical Journal Editors (ICMJE) recommendations, and applicable regulatory requirements. * Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific information to diverse internal and external audiences and facilitate cross-functional collaboration. * Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Microsoft Teams, and SharePoint. * Skilled in using Veeva Vault MedComms, Veeva PromoMats, publication management systems, and other platforms supporting scientific content development, review, approval, and distribution. * Strong scientific writing, editing, literature evaluation, and content development skills, with the ability to translate complex scientific information into clear, accurate, audience-appropriate materials. * Ability to leverage AI-enabled tools and platforms to support scientific content development, literature synthesis, data visualization, and operational efficiency while ensuring compliance with company policies and regulatory requirements. * Demonstrated project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines. Non-Technical Skills Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from concept to completion in a fast-paced environment.  Strong written and oral communication skills.  Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities.  Team player, flexible and adaptable. Ability to build good working relationships, both inside and outside the organization.  Self-starter.  Must possess integrity and be innovative in how they work on a day-by-day basis.  Has a passion for personal learning and development to be able to grow with the company.  Cultural sensitivity and ability to develop consensus within a multinational organization.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work Working Conditions: Minimal domestic travel required (<10%), primarily for conference attendance or key meetings; occasional weekend travel may be required.   The anticipated salary for this position will be $180,000 to $196,900.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The North America Head of Scientific Communications is a senior leadership role within NA Medical Affairs responsible for setting the strategic direction, oversight, and governance of scientific communications across the regional portfolio. This role ensures the delivery of high-quality, compliant, and impactful scientific communications that support evidence dissemination, medical education, and scientific exchange throughout the product lifecycle. The role provides leadership for regional publication strategy and execution, field medical resources, medical education content, digital scientific communications, congress activities, and regional medical review processes. The role leads and develops a high-performing scientific communications team and serves as a key strategic partner to Medical Affairs therapeutic area leaders, commercial team and cross-functional stakeholders. As a catalyst for innovation, the NA Head of Scientific Communications continuously evaluates emerging digital channels, data-driven insights, and evolving stakeholder engagement preferences to ensure Medical Affairs remains at the forefront of scientific exchange. This includes leveraging modern communication platforms and formats—including social media, podcasts, and other digital channels—to meet the evolving information needs of healthcare professionals, scientific experts, and key opinion leaders. Essential Functions: Future Pipeline Expansion & Capability Building * Proactively prepare NA Scientific Communications to support future pipeline expansion, including new therapeutic areas, indications, modalities, and lifecycle stages. * Anticipate scientific communications needs associated with pipeline progress and evolving portfolio complexity, including early asset planning, launch readiness, and post-launch evidence dissemination. * Design scalable scientific communications approaches, processes, and resourcing models that can flex with portfolio expansion. * Partner with Global Medical Affairs and Clinical Development to ensure early alignment of scientific narratives, data generation plans, and publication strategy for pipeline assets. * Identify capability gaps and lead continuous improvement initiatives across scientific communications, including talent development, vendor partnerships, and operational excellence.  Strategic Leadership & Governance * Develop and own the regional scientific communications strategy across multiple products, aligned with global medical strategy, portfolio priorities, and North America Medical Affairs objectives. * Establish and maintain regional governance frameworks, standards, and best practices for scientific communications across channels and formats. * Serve as a senior scientific communications advisor to North America Medical Affairs leadership and therapeutic area leads. * Ensure compliance with internal SOPs, Good Publication Practice (GPP), ICMJE guidelines, and all applicable regulatory, legal, and compliance requirements.  Publications & Evidence Dissemination * Oversee regional publication planning and execution, including abstracts, manuscripts, posters, oral presentations, and plain language summaries. * Ensure timely, high-quality execution of regional publication plans in collaboration with global partners, investigators, and external authors. * Provide strategic oversight of publication vendors and agencies, including scope, budgeting, and performance management.  Scientific Content & Medical Materials * Lead development and lifecycle management of regional scientific narratives, lexicons, and key data-driven messages. * Oversee creation, approval, and maintenance of regional field medical materials, including slide decks, FAQs, disease education materials, and data summaries. * Ensure all materials are scientifically accurate, strategically aligned, audience-appropriate, and tailored to regional needs.  Medical Education & Congress * Oversee scientific content for regional medical education, insight generation initiatives, advisory boards, and peer-to-peer scientific exchange. * Provide scientific communications leadership for regional congress strategy and execution, including content development, scientific booth materials, and symposia support. * Partner closely with Field Medical and Medical Education teams to align content with scientific objectives and stakeholder insights. Digital Scientific Communications * Provide strategic oversight of regional digital scientific assets, including modular and omnichannel-ready content, congress digital materials, and online educational resources. * Partner with digital and omnichannel teams to ensure scientific rigor, consistency, and effective data visualization across platforms.  Medical Review & Compliance Oversight * Lead and oversee regional medical review processes to ensure efficient, compliant, and high-quality review of scientific communications materials. * Serve as a senior medical/scientific reviewer and escalation point for complex scientific, regulatory, or compliance-related issues. * Drive continuous improvement of review workflows and cross-functional collaboration.  People Leadership & Talent Development * Lead, coach, and develop a team of scientific communications professionals, fostering a culture of scientific excellence, accountability, and collaboration. * Set clear objectives, provide ongoing performance feedback, and support professional development for direct reports. * Build and sustain a high-performing scientific communications function capable of supporting a growing and evolving portfolio. * Anticipate future portfolio and pipeline needs to inform thoughtful expansion of the scientific communications team over time. * Define future role profiles and succession plans to ensure the organization scales effectively as new assets and therapeutic areas are added to the portfolio.  Decision-Making Authority * Accountable for regional scientific communications strategy, priorities, and execution across the North America portfolio. * Final scientific approval authority for regional scientific communications materials within established governance and SOPs. * Authority to manage external vendors and agency partners. * Escalation authority for complex scientific, compliance, or reputational risk issues related to scientific communications. Strategic Partnerships & Cross-Functional Leadership * Serve as a strategic partner to North America Medical Affairs Leadership, Therapeutic Area Heads, Field Medical, Global Medical Affairs, and Global Scientific Communications to ensure alignment of scientific communication strategies and execution. * Collaborate closely with Clinical Development, HEOR, Regulatory Affairs, Legal, Compliance, Commercial, Digital, Omnichannel, and Alliance partners to develop and deliver impactful, compliant scientific communications and medical education initiatives. * Represent North America Scientific Communications on cross-functional governance committees, leadership forums, and strategic initiatives, providing scientific communications expertise and influencing organizational priorities. * Foster strong alignment between regional and global scientific communications strategies, ensuring consistency, operational excellence, and effective dissemination of scientific evidence across the product lifecycle. * Build and maintain productive relationships with external stakeholders, including investigators, scientific authors, vendors, and agency partners, to support high-quality scientific communication deliverables. Subordinates: Medical Communication Directors (2) and Senior Manager, PRC/MRC Job Requirements: Education Advanced Scientific or Clinical Degree: An earned Ph.D., Pharm.D., or M.D. in a relevant life sciences, biomedical, or clinical discipline is strictly required. Experience * Minimum 12+ years of experience in Medical Affairs, or related roles within pharmaceutical or biotechnology organizations, at least 6 years in Scientific/Medical Communication. * Senior leadership experience managing scientific communications teams and leading complex, cross-functional, matrixed initiatives at regional or global scale. * Extensive oversight of end-to-end scientific communications activities, including publications, medical education, field medical materials, congress strategy, and digital scientific content. * Strong understanding of publication planning standards, medical governance, and regulatory and compliance requirements within a highly regulated environment. * Experience serving as a strategic partner to Medical Affairs leadership, with ability to influence cross-functional stakeholders and align scientific communication strategies with enterprise objectives. * Background contributing to transformation initiatives in Medical Affairs, including modernization of scientific communications and evolution toward digital and omnichannel engagement models. * History of building, leading, and developing high-performing, multidisciplinary teams, including mentorship of managers and senior scientific communications professionals. * Experience operating within global or regional matrix organizations, ensuring alignment between regional execution and global scientific communications strategy.   Technical Skills & Competencies * Deep understanding of Medical Affairs operating models, governance structures, and the role of Medical Affairs across the product lifecycle, including its interface with Clinical Development, Regulatory, and Commercial functions. * Strong expertise in strategic planning, portfolio prioritization, and resource allocation within complex, global matrix organizations. * Comprehensive knowledge of Medical Affairs planning and execution, including scientific communications, publication planning, medical education, field medical strategy, evidence generation, and investigator-sponsored research activities. * Solid understanding of clinical development processes, regulatory requirements, compliance standards, and industry guidelines governing Medical Affairs operations. * Experience establishing and optimizing governance frameworks, operational processes, and performance metrics that enhance effectiveness, consistency, and scalability of Medical Affairs activities. * Ability to influence and align senior stakeholders across global and regional organizations without direct authority, driving consensus in highly matrixed environments. * Strong strategic acumen and business orientation, with the ability to translate enterprise priorities into actionable plans, clear governance structures, and measurable outcomes. * Advanced communication and executive presentation skills, with the ability to engage senior leadership and support informed, cross-functional decision-making. * Strong analytical capability, leveraging data, insights, and performance indicators to support prioritization, resource decisions, and continuous improvement. * Proficiency in business planning, portfolio tracking, and collaboration tools, with strong command of Microsoft Office applications (PowerPoint, Excel, and related tools).  Non-Technical Skills Ability to thrive in a fast-paced environment while managing ambiguity effectively. Strong work ethics are required. Passion for personal learning and professional development. Cultural sensitivity and adaptability within multinational organizations. The anticipated salary for this position will be $250,000 to $286,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery. Essential Functions: The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth. 1. Solution Architecture & Design •    Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.). •    Translate complex business requirements into clear, scalable, and compliant functional solutions. •    Emphasizes proactive, holistic leadership in solution architecture. •    Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance. •    Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems). •    Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices. 2. Implementation & Configuration •    Perform and lead the setup, configuration, and deployment of D365 F&O modules.  •    End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).  •    Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams. •    Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution. •    Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments. 3. Governance & Compliance •    Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements. •    Develop and maintain master data governance, change management, and configuration control processes. •    Support audits and inspections through proper documentation and traceability. •    Develop current and future state roadmaps and architecture. •    Assess and align system release plan with Microsoft Dynamics 365 roadmap 4. Stakeholder Collaboration •    Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology. •    Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.  •    Work closely with IT, OT, and cloud teams to ensure integrated digital architecture. •    Provide subject matter expertise and training for internal business process owners and super users. 5. Project & Vendor Management •    Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare. •    Manage and coordinate external implementation partners and vendors. •    Define KPIs and monitor system performance, adoption, and ROI. Requirements: Education  Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred. Experience •    8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O. •    Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement). •    Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.). •    Strong understanding of ERP data models, workflows, and reporting. •    Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules: o    Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management  o    SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks  Technical Skills •    Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower).  •    Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred. •    Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP. Working Conditions: Requires up to 10 % domestic and international travel The anticipated salary for this position will be $165,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Manager, ICT Delivery plays a critical role in delivery of complex technology projects and IT services. They combine strategic planning with tactical execution to align team output with broader organizational goals, managing everything from initial scoping to final deployment and post-launch support.  They ensure that digital initiatives are executed efficiently, securely and in alignment with GxP standards. They exhibit strong delivery leadership with a deep appreciation for the complexities of the pharmaceutical environment. Essential Functions: •    Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives. •    Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards. •    Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations. •    Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions. •    Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting. Additional activities may include, but are not limited to: •    IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track. •    Stakeholder Communication & Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints. •    SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness. •    Issue Resolution & Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines. Requirements: Education Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required Experience At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements;  Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics Technical Skills Proficient in MS Office Suite. Working Conditions: Requires up to 10% domestic and international travel The anticipated salary for this position will be $121,000 to $156,800.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

We're looking for a Junior R&D Lab Engineer to join our forward-thinking, dynamic team and help us create game-changing sensor systems for the biopharmaceutical industry. Do you want to be part of a growing company that's shaping new possibilities in the field? Come join us at ArgusEye — a growing company of around 15 people — and be part of our journey! About the role: You'll be part of a small but growing R&D team of six people dedicated to our sensor development. Your primary focus will be the development of new sensor chips and to test new hardware, a role where your ideas and skills will directly influence the future of our technology. This means planning, designing, and executing experiments related to sensor development and characterization, as well as improving existing solutions. You'll get hands-on with manufacturing processes and surface chemistry, using techniques such as HPLC and other analytical methodologies to evaluate sensor performance. You’ll contribute not only to the development of our technology, but also to shaping how we work, build collaborations, and drive our future growth. What you'll do with assistance: Plan, design, and execute experiments related to the development and characterization of new sensor chips. Generate high-quality data to support the development of better data models. Contribute with ideas and concepts for sensor chip design and fabrication. Develop and validate new product prototypes for various applications. Maintain laboratory notebooks and electronic records in line with data quality and integrity standards. Prepare scientific reports, protocols, and presentations for internal and external stakeholders. Perform regular lab maintenance to ensure a clean and safe work environment. Collaborate closely with other team members to successfully integrate sensor chips into our systems. We’re looking for someone who.. ..loves lab work and believes that great technology starts with curiosity and experimentation. You thrive in a collaborative environment and want to be part of a team where innovation happens every day, and where you can help shape both technology and company culture. About you: Hands-on lab experience, including chemical handling, experiments, and use of standard lab equipment in a wet lab, gained through work experience or academic studies, is required Holds relevant Master’s degree in for example Material science, Biomolecular chemistry, or Bio- and Nanomaterials Strong understanding of organic reactions and surface chemistry applied to sensor development Passion for problem-solving, innovation, and scientific exploration Analytical skills and experience in surface characterization and performance evaluation is a plus Why join us? Work on cutting-edge technology with real-world applications. Be part of a supportive, dynamic team where your contributions are valued. Grow your career in an innovative, fast-paced industry. Learn from our customers and attend industry and R&D conferences to grow professionally. Enjoy the freedom to take ownership of your work, supported by a flexible and relaxed environment that values responsibility. Experience a family-like atmosphere filled with collaboration, curiosity, and team activities like music quizzes, bowling and Friday fika. About ArgusEye: ArgusEye is on a mission to revolutionize biopharmaceutical production. Today, developing life-saving medicines is often a slow, complex, and expensive process, putting vital treatments out of reach for many. By providing advanced sensor systems for real-time monitoring of biological processes, we aim to change that. Our technology, built on 40+ years of research at Linköping University, combines nanoplasmonic sensing with fiber optics to deliver real-time data, speeding up medicine development, improving efficiency, and cutting costs. With partnerships among leading pharmaceutical companies and growing demand, we're scaling to make a bigger impact. At ArgusEye, you'll be part of a close-knit team where your ideas and contributions are truly valued. Together, we're making cutting-edge technology accessible to improve lives worldwide. START: Immediately LOCATION: Linköping JOB HOURS: Full-time CONTACT: Senior Recruiter Mikaela Ehk, mikaela.ehk@oddwork.se (contact for questions regarding the position, not applications) LAST APPLICATION DATE: Applications are reviewed on ongoing basis As a leading recruitment and employer branding company we challenge expectations and match talents with the right corporate culture while helping organizations create stronger employer brands. Curious and want to know more? Step into the world of Oddwork by clicking here or find more career opportunities here!

Job Scope High level purpose of function.  Responsible for the development, validation, and execution of the methods used for material analysis, including incoming material, intermediate, and finalized products for Research & Development and Production on a wide range of instruments. Strict adherence to the principles of Quality Assurance in Quality Control (QA/QC). Proven track record in statistical analysis and measurement system analysis (MSA).  Key Responsibilities Overall areas of responsibilities and activities. Key responsibilities include (but are not limited to)  Responsible for a set of instrumentation or measurement systems. This involves, but not limited to, coordinating maintenance and troubleshooting, writing support documentation, training and qualifying personnel, performing method development and validation.   Understand and internalize QA/QC principles in everyday functions.   Conduct analysis on a wide range of instruments and report data/results for a diverse set of samples.   Execute the Quality Control and testing plan of material and components.  Maintaining instruments and measurement areas to a high standard, involving ownership of room(s)/area(s) to drive safety related topics, ensure 5S, maintain consumable inventory and standards/reference samples. Work across many parts of the organization, collaborating with R&D technical team, Process Quality Engineering, Process Engineering, Supply Chain, IT & automation.   Drive operational excellence and investigations by being a key player in problem solving and process improvement exercises.   Accountability/Authorization Budget responsibility: No  Direct reports: No  Work Environment responsibility: No All employees are accountable for complying with safety regulations and actively supporting a safe workplace. Requirements Educational background and previous experience required for the role. Qualifications and experience  Minimum MSc degree or Bachelor’s degree with 5+ years of work experience in a laboratory, in Chemistry, Material or Mechanical Engineering. 3+ years of relevant work experience in relevant laboratory environment.   Experience of laboratory work in relevant industries such as, e.g. Li-ion materials, Pharmaceutical, Food and Paper industries or automotive industries.   Experience in developing methods, standards, procedures, and documentation in an efficient way.   Familiarity with Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Control Plan (CP), Lean, Six Sigma , Quality troubleshooting tools and problem-solving methodology.     Specific skills & Knowledge Specific knowledge in any relevant instrumentation, measurement system, or scientific field used by the company. Knowledgeable in Laboratory Information Management System (LIMS), quality management systems, e.g. ISO 9001, IATF16949, Total Quality Management (TQM).   Project management skills and a successful track record of leading quality projects in a laboratory environment.   Excellent English skills, both written and oral, are essential. Basic Swedish and other language skills are a plus. You should have good communication skills and be able to work in close collaboration with colleagues from many different teams.

Are you looking for an opportunity to work in a fast paced and highly regulated environment where your work directly supports clinical trials and the development of new medicines? We are currently seeking a Material Management and Distribution Operator for an exciting assignment within the pharmaceutical industry. About the Role As a Material Management and Distribution Operator, you will play a key role in ensuring that investigational medicinal products are handled, packed and distributed efficiently and in compliance with GMP requirements. You will join a collaborative team working in a dynamic environment where flexibility, quality and attention to detail are essential. The role focuses on operational activities within material management and distribution, supporting the supply of clinical trial products to study sites around the world. Key Responsibilities • Prepare and maintain documentation related to the handling and distribution of investigational medicinal products • Receive, manage and pack materials for clinical studies • Perform and document operational activities in accordance with GMP procedures and quality standards • Act as a point of contact for distribution related questions within assigned studies • Support continuous improvement initiatives and process development activities • Manage deviations and contribute to quality assurance activities • Develop, review and maintain procedures and work instructions within the area of responsibility • Support training and compliance related activities • Maintain facilities and equipment according to GMP requirements • Participate in projects and cross functional activities by contributing specialist knowledge and operational expertise Qualifications To be successful in this role, you should have: • Experience working within the pharmaceutical, biotechnology, medical device or another regulated industry • Knowledge and understanding of GMP requirements • Strong attention to detail and a quality focused mindset • The ability to work independently as well as collaboratively within a team • Good organisational and communication skills • Fluency in English, both written and spoken Experience in material management, logistics, warehousing or distribution within Life Sciences is considered an advantage. What We Offer This is an opportunity to contribute to important clinical development activities while working in a professional and innovative environment. You will be part of a team that values collaboration, quality and continuous improvement. About Hays Hays is one of the world's leading recruitment and workforce solutions companies, operating in more than 30 countries. We connect talented professionals with organisations across industries including Life Sciences, Engineering, Technology and Supply Chain. As a consultant through Hays, you will receive dedicated support, competitive employment conditions and access to exciting assignments with some of the world's most recognised organisations.

Senior Medical Writer - Publications Nucleus Global is an exciting leader in the field of medical communications. Drawn together from several backgrounds including the pharmaceutical industry, research, marketing, medical and regulatory writing, sales, publishing, digital media and design, we have the experience and all-round ability to conceive and deliver the best quality medical communications programs. About the role As a Senior Medical Writer, you will use your scientific expertise to develop and deliver innovative medical communications projects. This is an excellent opportunity for an experienced medical writer seeking professional growth and progression. Here's what you'll be doing: * Take the lead role in projects where required and take ownership of the scientific/editorial component. * Responsible for producing high-quality scientific written materials in keeping with project briefs. * Assist with editing and proofreading of text written by other team members and provide constructive feedback to aid learning and development. * The role will involve reviewing and interpreting data from preclinical and clinical research articles as the basis of creating scientific written materials in keeping with project briefs. * Remains current with medical developments and conducts literature searches to ensure delivery of accurate medical information for assigned projects. * Participate in client meetings / teleconferences and attend scientific meetings as required. * Synthesizes clinical trial data and translates relevance for the appropriate physician and consumer audiences according to client requirements for assigned projects. About you: * Advanced degree in life sciences, pharmacology or medicine  * Excellent written and verbal communication and interpersonal skills * Ability to thrive in a fast-paced environment, work to and within deadlines and to juggle multiple projects * Strong financial, administrative and organization skills, including ability to multi-task * 2+ years of relevant experience within medical communications * Keen attention to detail, ability to prioritize responsibilities and work in a team-oriented environment as well as independently * Advanced computer skills, knowledge of Internet searches and Microsoft Windows software including Word, Excel (can maintain complex spreadsheets) and PowerPoint. * Travel as needed, including weekends Benefits: * Health coverage * Retirement plan * PTO Nucleus Global can offer an attractive rewards package, excellent training and development opportunities, a supportive and friendly environment and the opportunity to achieve your potential. Our Pledge At Nucleus Global, we value inclusivity, recognize the power of diversity and inspire the next generation of change-makers. We are an equal opportunities employer. We believe in creating a dynamic work environment that values diversity, equity and inclusion. We aim to recruit from a diverse slate of candidates and foster an environment that provides the right conditions for long-term success. We welcome all applications regardless of race, color, religion or belief, gender, gender identity, age, national origin, marital status, military veteran status, genetic information, sexual orientation and physical or mental disability. Nucleus Global is part of Inizio Medical. Inizio is a strategic partner for health and life sciences with a full suite of medical, marketing, advisory and engagement services. The base salary range represents the low and high end of the salary range for this position. This range may differ based on your experience and skill set, geographic location, and cost of living considerations. We consider compensation more than just a base salary – that’s why we also offer an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. Compensation $1—$1 USD Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

About the role At Navinci, we are passionate about understanding biology and disease at a deeper level. We develop technologies and applications that help researchers study proteins, signaling pathways, cellular biology, and molecular mechanisms directly in biological samples. Our work spans tissue and cell-based systems and increasingly combines information from multiple technologies and data types to generate richer biological insight. We collaborate with leading academic groups, biotech companies, and pharmaceutical partners worldwide to advance research and translational science. As we continue to grow, we are looking for 2–3 scientists with different backgrounds and expertise to join our R&D team. We are interested in people who are excited by science, enjoy solving complex problems, and want to contribute to the development of innovative research tools and technologies. Whether your background is in cell biology, tissue biology, spatial biology, immunology, biomarker research, assay development, translational science, omics technologies, or technology development, we would love to hear from you. What you will do Design, execute, optimize, and troubleshoot biological assays and laboratory experiments Analyze and interpret data, generate robust and reproducible results, and communicate clear conclusions Document experimental work according to quality standards and contribute to scientific decision-making Collaborate across R&D, Operations, and Commercial teams Support development of new applications, products, technologies, and improved ways of working Must-have qualifications MSc or PhD in Biotechnology, Molecular Biology, Cell Biology, Biochemistry, Immunology, Medical Science, or a related field Hands-on experience with immunofluorescence, immunohistochemistry (IHC), and other in situ staining and detection methods Experience working with both tissue samples and cell-based models Experience designing, executing, and troubleshooting biological experiments Strong skills in data analysis and presentation, experimental planning, and scientific documentation Fluent in English, written and spoken Experience in one or more of the following areas Cell culture and primary cell models RNA-based methods, transcriptomics, or other omics technologies Flow cytometry Multiplex imaging, microscopy, image analysis, or digital pathology Protein biomarker analysis and antibody-based assays Assay, application, or product development Translational research, biomarker discovery, or disease biology (e.g., oncology, immunology, neuroscience) Statistical analysis, automation, quality systems Industrial R&D, scientific publications, grant writing or patent-related activities Who you are Curious, innovative, and eager to solve scientific challenges Agile and adaptable, with the ability to work in a fast-moving environment Structured, organized, and committed to high scientific quality Hands-on, proactive, and solution-oriented Collaborative, supportive, and comfortable taking ownership of your work

Scientific Director - Promotional Nucleus Global is an exciting leader in the field of medical communications. Drawn together from several backgrounds including the pharmaceutical industry, research, marketing, medical and regulatory writing, sales, publishing, digital media and design, we have the experience and all-round ability to conceive and deliver the best quality medical communications programs. About the role The Scientific Director will be the key scientific lead on a variety of promotional accounts (obesity/cardio metabolic), providing editorial, scientific, and strategic expertise to our client teams. Experience Working in partnership with Client Services, you will help to establish a cohesive and dynamic relationship between the accounts and editorial teams and the client, leading discussions in client meetings/teleconferences (as required) to ensure client satisfaction is maintained at all levels. Here's what you'll be doing: * Responsible for ensuring that assigned medical communications are accurate, clinically relevant and reflect the most recent advances in the medical field. * Consults with key opinion leaders in the appropriate therapeutic area and provides expert resources and information. * Maintains knowledge of developments and trends in the pharmaceutical industry regarding appropriate drugs * Will partner with pharmaceutical industry clients on goals and objectives of communications programs, ensuring delivery of the highest quality product. * Remains current with medical developments and conducts literature searches to ensure delivery of accurate medical information for assigned projects. * Synthesizes clinical trial data and translates relevance for the appropriate physician and consumer audiences according to client requirements for assigned projects. * Attends and helps design clinical trial investigator meetings and advisory boards. * Help write medical manuscripts, white papers, monographs, slide kits, abstracts, and posters under the supervision of senior scientific staff. * Edits medical documents, verify scientific accuracy and provide quality control for writers and freelancers. About you: * Advanced degree in life sciences, pharmacology or medicine  * Excellent written and verbal communication and interpersonal skills * Ability to thrive in a fast-paced environment, work to and within deadlines and to juggle multiple projects * Strong financial, administrative and organization skills, including ability to multi-task * Strong client communication skills – ability to speak and work with client and faculty members * Keen attention to detail, ability to prioritize responsibilities and work in a team-oriented environment as well as independently * Advanced computer skills, knowledge of Internet searches and Microsoft Windows software including Word, Excel (can maintain complex spreadsheets) and PowerPoint. * Travel as needed, including weekends Benefits: * Health coverage * Retirement plan * PTO Nucleus Global can offer an attractive rewards package, excellent training and development opportunities, a supportive and friendly environment and the opportunity to achieve your potential. Our Pledge At Nucleus Global, we value inclusivity, recognize the power of diversity and inspire the next generation of change-makers. We are an equal opportunities employer. We believe in creating a dynamic work environment that values diversity, equity and inclusion. We aim to recruit from a diverse slate of candidates and foster an environment that provides the right conditions for long-term success. We welcome all applications regardless of race, color, religion or belief, gender, gender identity, age, national origin, marital status, military veteran status, genetic information, sexual orientation and physical or mental disability. Nucleus Global is part of Inizio Medical. Inizio is a strategic partner for health and life sciences with a full suite of medical, marketing, advisory and engagement services. Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.