Sökresultat för "Pharmaceutical"

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.

NU-sjukvården är en del av Västra Götalandsregionen och är ett av Sveriges större länssjukhus. Vi finns på NÄL (Norra Älvsborgs Länssjukhus) i Trollhättan och Uddevalla sjukhus. Sjukhusets upptagningsområde omfattar 280 000 invånare. Tillsammans är vi cirka 5 000 medarbetare som varje dag arbetar för att ge god och säker specialistsjukvård. Vi finns på västkusten och vårt område erbjuder en varierad natur med både hav, berg, skog och sjö. Beskrivning Sjukvårdsapoteket NU-sjukvården är en del i det regionala sjukvårdsapoteket VGR och ansvarar för förvaltningens samlade läkemedelsarbete. På sjukvårdsapoteket arbetar drygt 50 medarbetare med olika kompetenser såsom apotekare, receptarie, sjuksköterska och läkemedelsassistent. I enhetens uppdrag ligger ansvar för läkemedelsförsörjning, läkemedelshantering, sortimentsarbete, tillverkning av extempore läkemedel (cytotstatika) samt information om läkemedel, allt i nära samarbete med vårdverksamheterna. Arbetsuppgifter Arbetet innebär ett nära samarbete med vårdverksamheter och ett teamarbete inom sjukvårdsapoteket. Du kommer att arbeta med extemporetillverkning. Du kommer att medverka i Extemporetillverkning av cytostatikaberedningar där du så småningom även kommer att få utföra orderhantering och slutkontroll, dvs frisläppande av produkt. Det kan även förekomma kliniska prövningar i form av tillverkningsstudier. Kvalifikationer Du är legitimerad apotekare eller legitimerad receptarie med formell behörighet för extemporetillverkning.  Du är noggrann, ansvarsfull och har fokus på patienten. Du har god förmåga att samarbeta i team och har lätt för att skapa nya kontakter och goda relationer. Du har lätt för att uttrycka dig i tal och i skrift. Då vi arbetar med korta ledtider är det också viktigt att du är stresstålig, serviceinriktad och flexibel.  Arbetet ställer krav på goda IT kunskaper. Vi kommer lägga stor vikt vid personlig lämplighet. Övrigt Annonsen avser ett vikariat som sträcker sig 12 månader framåt, med eventuell möjlighet till förlängning. Urval och intervjuer kommer att ske fortlöpande vänta därför inte med din ansökan. Välkommen med din ansökan! Tjänsten kan komma att placeras i säkerhetsklass. Det innebär att säkerhetsprövning och registerkontroll kan komma att genomföras i enlighet med bestämmelser i säkerhetsskyddslagen före anställning. Om Västra Götalandsregionen Hos oss blir du en del av en större helhet. Vi är 56 000 medarbetare i över 200 yrken som varje dag gör skillnad i människors liv i hela Västra Götaland.  Du bidrar till en trygg och jämlik vård samt till ett hållbart samhälle där miljö, kultur och goda kommunikationer skapar livskvalitet.  Vi är mitt i en digital utveckling där du får vara med och forma framtidens arbetssätt för att förbättra och förenkla vardagen för invånare och verksamheter.  Som tillsvidareanställd blir du krigsplacerad som en del av vårt gemensamma ansvar för att samhällsviktiga funktioner ska fungera även i kris.  Vill du veta mer om oss? På vår webb kan du läsa mer om våra förmåner och möta medarbetare som varje dag gör skillnad och utvecklas i sina yrken. https://www.vgregion.se/jobba-i-vgr/sa-ar-det-att-jobba-hos-oss/  Ansökan Västra Götalandsregionen ser helst att du registrerar din ansökan via rekryteringssystemet. Om du som sökande har frågor om den utannonserade tjänsten eller av särskilda och speciella skäl inte kan registrera dina uppgifter i ett offentligt system - kontakta kontaktperson för respektive annons. Till bemannings-, förmedlings- och rekryteringsföretag och till dig som är försäljare: Vi undanber oss vänligen men bestämt direktkontakt med bemannings-, förmedlings- och rekryteringsföretag samt andra externa aktörer och försäljare av ytterligare jobbannonser. Västra Götalandsregionen har upphandlade avtal.

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. This position requires being onsite two days a week in our Princeton, NJ HQ. This is note a remote opportunity. Summary of Job: The Senior Medical Director, Global Medical Affairs – Oncology is responsible for leading the development and execution of global medical affairs strategies for oncology programs, with a focus on myeloid malignancies. This role provides medical and scientific leadership across assigned assets and supports the integration of medical strategies with broader corporate objectives. The incumbent will lead global medical activities related to evidence generation, scientific communication, and external engagement, including collaboration with alliance partners and key external stakeholders. The position works cross-functionally with Clinical Development, Commercial, Regulatory, Market Access, and other internal teams to ensure alignment and effective execution of medical affairs initiatives. This role requires deep expertise in oncology and or hematology, strong strategic and analytical capabilities, and the ability to lead complex, cross-functional initiatives in a global environment. Essential Functions: * Lead the development and execution of global medical affairs strategies for assigned oncology assets, including pre-launch planning, lifecycle management, and long-term strategic initiatives focused on myeloid malignancies. * Serve as the primary global medical scientific lead for healthcare decision-makers and external stakeholders, facilitating scientific exchange regarding disease state management and the clinical and economic value of oncology products. * Collaborate cross-functionally with Clinical Development, Research & Development, HEOR, Market Access, Commercial, Regulatory, and other internal stakeholders to ensure alignment of medical strategies with corporate and portfolio objectives. * Lead integrated evidence generation strategies and medical data generation plans, including company-sponsored clinical trials, investigator-sponsored studies, and real-world evidence initiatives. * Provide strategic medical leadership for alliance partnerships by collaborating with partner companies to align on shared medical strategies, evidence generation activities, and external engagement plans across joint oncology programs. * Oversee the execution and quality of ongoing medical affairs studies and activities to ensure scientific rigor, compliance with regulatory requirements, and alignment with organizational objectives. * Identify evidence gaps, emerging scientific trends, and external insights to inform medical strategy, portfolio development, lifecycle planning, and stakeholder engagement activities. * Build and maintain strategic relationships with key opinion leaders (KOLs), healthcare systems, advocacy organizations, payer organizations, and other external stakeholders globally. * Represent the organization at scientific congresses, advisory boards, investigator meetings, and other external forums to communicate medical and scientific data and support organizational thought leadership in oncology. * Coordinate global medical affairs activities with alliance partners and internal stakeholders to support seamless execution of shared medical initiatives and external engagement strategies. * Provide leadership, coaching, and development for direct reports and/or junior medical affairs team members, including performance management, mentoring, and fostering a collaborative, high-performing team culture. * Supervise and manage assigned personnel, consultants, vendors, and external collaborators, as applicable, to ensure effective execution of medical affairs objectives and adherence to company policies and compliance standards. Job Requirements:  Education Medical Doctor. Board certification and/or subspecialty training in Oncology and/or Hematology preferred.  Experience * Minimum of 10 years of experience in Medical Affairs within the pharmaceutical and/or biotechnology industry, including significant experience in oncology; hematology and/or myeloid malignancy experience strongly preferred. * Combination of Global and Regional/Country Medical Affairs experience strongly preferred, including experience supporting global product strategy and execution. * Demonstrated experience developing and executing global medical affairs strategies across multiple stages of the product lifecycle, including pre-launch and post-launch activities. * Proven track record of leading cross-functional initiatives and influencing matrixed teams across Medical Affairs, Clinical Development, Commercial, HEOR, Market Access, and Regulatory functions. * Experience leading evidence generation activities, including company-sponsored studies, investigator-sponsored research, and/or real-world evidence initiatives. * Demonstrated success engaging with external stakeholders, including key opinion leaders (KOLs), healthcare decision-makers, advocacy organizations, and payer audiences in global markets. * Proven ability to collaborate effectively with alliance partners, external collaborators, and co-development/co-commercialization partners. * Strong people leadership capabilities, including mentoring, coaching, and direct management of medical affairs personnel and/or cross-functional teams. * Proven ability to represent the organization at scientific congresses, advisory boards, investigator meetings, and other external scientific forums. * Strong knowledge of HEOR disciplines, biostatistics, clinical trial design, and evidence-based medicine principles. * Exceptional interpersonal, communication, presentation, and organizational skills. * Strategic thinking with demonstrated ability to influence stakeholders across matrix environments.  Technical Skills * Strong knowledge of oncology medical affairs, including evidence generation, scientific exchange, and product lifecycle support within global markets. * Advanced understanding of HEOR disciplines, biostatistics, clinical trial design, real-world evidence, and evidence-based medicine principles. * Strong scientific acumen with the ability to interpret, analyze, and communicate complex clinical and scientific data to diverse stakeholder audiences.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work. Working Conditions: Requires up to 35% domestic and international travel The anticipated salary for this position will be $256,800 to $335,400.  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 #LI-Hybrid

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. 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 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 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

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

Jobba för originalet. Välkommen till Apoteket, nummer ett sedan 1971. Med visioner för framtiden och kvalitet i varje detalj, skapar vi förutsättningar för ett liv i hälsa. Hos oss utvecklas du i en kultur där din röst alltid blir hörd. Och allt vi får över ger vi tillbaka till samhället. Det är så vi gör skillnad på riktigt. Om Apoteket Svanen Hos oss på Apoteket Svanen blir du en del av ett engagerat och stabilt team i Markaryd. Apoteket ligger nära en vårdcentral och vi är stolta över våra många stamkunder och de goda relationer vi bygger i vårt dagliga arbete. Utöver våra kunder som besöker oss har vi andra arbetsuppgifter vilket skapar en god variation i vårt vardagliga arbete. Här arbetar tre farmaceuter, inklusive apotekschefen och en tekniker, vi är ett sammansvetsat gäng som samarbetar prestigelöst och hjälps åt i vardagen. Arbetstiderna för denna tjänst ligger inom ramen för det lokala apotekets öppettider: vardagar 09.00-18.00, lördagar & söndagar stängt. Din roll Våra farmaceuter arbetar alltid med omtanke, kvalitet och kundens behov i fokus. I din roll hos oss bidrar du till en trygg, professionell och välkomnande upplevelse för alla som besöker oss. I din roll har du hand om rådgivning, receptexpedition och egenvård, och tar ansvar för trygghet och service i varje kundmöte. Vi vill ge dig möjligheter att utvecklas och för denna tjänst finns det möjlighet att ta rollen som exempelvis LMA för den som är intresserad. Vad du kommer att göra hos oss: Ge professionell rådgivning och skapa mervärde i varje kundmöte, med omtanke och förståelse för människors olika behov. Bidra till patientsäkerhet och kvalitet i allt du gör, så att våra kunder kan känna sig trygga med oss. Dela kunskap och erfarenhet med dina kollegor – vi växer och utvecklas tillsammans. Hålla dig uppdaterad kring vårt sortiment och våra kampanjer, för att ge kunderna bästa möjliga hjälp. Bidra med idéer och initiativ för att utveckla både arbetsvardagen och kundupplevelsen på vårt apotek. Vem söker vi? För den här tjänsten behöver du vara legitimerad receptarie eller apotekare, med ett tydligt intresse för människor, hälsa och läkemedel. Du kan antingen vara nyexaminerad eller har erfarenhet som farmaceut på apotek sedan tidigare. Det är meriterande om du har ett intresse och erfarenhet av att arbeta som LMA. Du har ett varmt och professionellt bemötande där du ser varje kund. Du samarbetar gärna och bidrar positivt till team. Vi tror att du trivs i ett sammanhang där struktur och resultat går hand i hand. Vi erbjuder... Friskvårdsbidrag: 5000 kr per år. Personalrabatt: Förmånliga priser på många av våra produkter. Flexibla helgdagar: Möjlighet att byta arbetsfria helgdagar mot andra dagar på året. Förmånsportal (Benifex): Erbjudanden inom bland annat kollektivtrafik, leasingbil, gym och hälsobehandlingar. Trygga försäkringar: Förstärkt föräldrapenning, tjänstepension (ITP) och kompletterande försäkringar. Om oss Apoteket grundades 1971 och ägs av svenska staten, vilket innebär att vi arbetar både ansvarsfullt och långsiktigt. Vårt viktiga samhällsuppdrag handlar om att förbättra människors hälsa, läkemedelsanvändning och bidra till ökad patientsäkerhet. Med omkring 400 apotek och 3000 medarbetare över hela landet har vi nära samarbete med hälso- och sjukvården – alltid med omtanke om både människor och miljö. Vårt mål är tydligt: Ett liv i hälsa, för alla. Nyfiken? Det räcker gott. Hör av dig om rollen fångar ditt intresse! Vi berättar gärna mer om tjänsten och vår verksamhet – så du får en tydligare bild och kan avgöra om det känns helt rätt. Vänta bara inte för länge, urval och intervju sker löpande och tjänsten kan tillsättas innan sista ansökningsdatum. Skicka ditt CV tillsammans med svar på våra urvalsfrågor. Du behöver inte skriva ett personligt brev – frågorna är utformade för att hjälpa oss förstå mer om dina erfarenheter och kompetenser för matchning mot tjänst. Vi använder tester för objektivt urval som en del av vår rekryteringsprocess. Provanställning tillämpas. Välkommen till Apoteket!

Beskrivning av jobb Är du legitimerad farmaceut och är redo för din nästa utmaning? Vill du vara en del av en organisation där du kommer att ha ett nära samarbete med ditt team och stora möjligheter att utvecklas i olika roller? Välkommen till Apotek Hjärtat! Om jobbet som farmaceut på Hjärtat Som farmaceut på Hjärtat arbetar du omväxlande med rådgivning och försäljning inom recept och egenvård. I rollen bidrar du med din farmaceutiska kompetens, engagemang och erfarenhet, till en bättre hälsa för våra kunder och till apotekets framgång. På Hjärtat kan din karriär som farmaceut ta många spännande vägar. Du kan leda andra och specialisera dig inom till exempel farmaci, kvalitet eller kundmöte. Möjligheterna är många! Läs mer om våra karriärvägar här. Därför ska du jobba hos oss - apotekschefen berättar Vi söker dig som är en engagerad farmaceut som vill leverera riktigt bra kundservice tillsammans med oss. Vi har ett stort utbud av egenvård på vårt apotek och en kundgrupp som uppskattar vår kompetens inom området egenvård i kombination med rådgivning vid recepthantering. Hos oss får du också mölighet till omväxling genom att vid behov även stötta vår e-handel med kundmöten på distans. Vi arbetar som ett lag och ser en glädje i att gemensamt nå uppsatta försäljningsmål och vi gärna firar tillsammans när vi lyckas. Vi söker därför dig som vill bidra till det genom att dela kunskap via ett coachande förhållningssätt mellan kollegor. För mig som chef, är det av stor vikt att du är engagerad, målinriktad och tar egna initiativ i din roll som farmaceut och ser till att kundens behov med rådgivning och säkerställande av rätt läkemedelsanvändning uppfylls samt att du brinner för mervärdesförsäljning och bidrar till en god laganda för att nå våra gemensamma mål. Vi har öppet vardagar 08–18, lördagar 10–15 och söndagar 10–15. Vi är ett härligt team som ger det lilla extra i varje kundmöte. Tjänsten är tillsvidare. Tjänsten är på heltid alternativt deltid. Tillträde till tjänsten sker snarast möjligt eller enligt överenskommelse. Är du den vi söker? Vi söker dig som är legitimerad receptarie eller apotekare. Du är antingen i början av din karriär eller erfaren farmaceut och känner igen dig i beskrivningen: Du visar intresse och engagemang i mötet med kunder och samarbetar väl med kollegor på ditt apotek och i hela regionen/ hela Apotek Hjärtat Du tar ansvar för att hantera de krav som ställs på dig som farmaceut och tar hjälp av ditt team vid behov Du bidrar med en god attityd och söker enkla lösningar i vardagen Nyfiken på att lära känna våra kollegor? Lyssna på vår podcast. Du hittar den här! På Hjärtat strävar vi efter en jämn könsfördelning och ser mångfald som en styrka. Vi välkomnar därför sökande med olika bakgrund! Intervjuer sker löpande och tjänsten kan komma att tillsättas innan sista ansökningsdagen, skicka in din ansökan redan idag. Om roller kräver det så behöver du genomgå bakgrundskontroller innan anställning. All extern hjälp med rekrytering undanbedes. Sista ansökningsdag: 20326-09-30 Kontaktperson: Sara Almqvist Välkommen till oss - ett apotek med Hjärtat på rätt ställe!

På Läkemedelsverket gör vi skillnad tillsammans. I livet och för livet. Vi jobbar för människors och djurs hälsa, för ett bättre Sverige idag och i framtiden. Vill du använda din kompetens inom kvalitetssäkring av läkemedelstillverkning eller partihandel med läkemedel, har ett öppet, objektivt förhållningsätt och ett genuint intresse för inspektioner? Har du goda kunskaper om GMP eller GDP? Sök jobb hos oss! Vår verksamhet Enheten för inspektion av industri och sjukvård ansvarar för tillsyn av kliniska prövningar, tillverkning, distribution och system för säkerhetsövervakning av läkemedel. Tillsynen omfattar aktörer inom industri och sjukvård och bedrivs huvudsakligen via fältinspektioner både nationellt och internationellt. Vi deltar även aktivt i utformning av regelverk och riktlinjer inom respektive område. För närvarande arbetar drygt 40 personer på enheten indelade i fem grupper: inspektion GMP/GDP 1 och 2, inspektion GVP/GCP, inspektion sjukvårdsnära tillverkning samt inspektion kansli. Vi söker nu nya kollegor till grupperna inspektion GMP/GDP 1 och 2. Dina arbetsuppgifter Arbetet som inspektör består till stor del av fältinspektioner av läkemedels- och substanstillverkning, import respektive partihandel.  Som ny inspektör får du en gedigen introduktion till inspektionsarbetet anpassad efter tidigare erfarenhet och efter certifiering kommer du att delta i och leda inspektioner. Med mer erfarenhet från inspektioner kommer nationella inspektioner att varvas med internationella inspektionsuppdrag för bland annat EMA (European Medicines Agency). Som inspektör kommer du att ingå i olika arbetsgrupper och samarbeta med andra verksamheter inom Läkemedelsverket och förväntas bidra i hantering av olika ärenden samt till samsyn och harmonisering vad gäller regelverk och inspektionsverksamhet. I arbetsuppgifterna ingår även att informera om regelverk i olika sammanhang samt hantera inkommande frågeställningar ifrån företag, andra myndigheter eller allmänheten. Baserat på tidigare erfarenheter finns olika vägar att utvecklas framåt i en expertroll hos oss. Det finns goda möjligheter att vidareutvecklas i rollen med till exempel deltagande i nationella och internationella arbetsgrupper. Din bakgrund Vi söker dig som har en naturvetenskaplig universitets- eller högskoleexamen och mångårig, gedigen yrkeserfarenhet från kvalitetssäkring av läkemedelstillverkning eller partihandel med läkemedel. Du har goda aktuella kunskaper om GMP och GDP och vi ser gärna att du har god insikt i regelverk gällande kvalitet och godkännande av läkemedel. Du bör till stor del uppfylla de formella kraven för sakkunnig person (QP) enligt HSLF-FS 2021:102. Det är meriterande om du har erfarenhet från kommersiell läkemedelstillverkning, inspektioner/auditering eller om du har arbetat som sakkunnig person (QP eller RP). Det är även meriterande om du har djupare kunskaper inom tillverkning av aktiva substanser, sterila eller biologiska läkemedel. Det dagliga arbetet ställer krav på mycket god förmåga att kommunicera i tal och skrift på såväl svenska som engelska. Körkort är ett krav i och med att arbetet medför regelbundna resor. Dina personliga egenskaper Du har hög integritet och god analytisk förmåga. Arbetet som inspektör kräver god kommunikations- och samarbetsförmåga samt ett strukturerat arbetssätt från planering till genomförande och rapportering av inspektioner. Du behöver kunna granska och utvärdera uppgifter från olika system, prioritera och självständigt fatta beslut även under tidspress vid fältinspektioner. Du har ett nyfiket förhållningssätt och är öppen för att ta in ny information. Du är tydlig i din kommunikation med andra såväl internt som externt samt värnar om ett gott bemötande. Vi lägger stor vikt vid personlig lämplighet. Bra att veta Sista ansökningsdag: 2026-09-04   Anställningsform: Tillsvidare   Tillträde: Enligt överenskommelse   Enhet: Inspektion av industri och sjukvård   Diarienummer: 2.4.1-2026-051207   Vi tillämpar 6 månaders provanställning.   Vi värdesätter mångfald och välkomnar sökande med olika bakgrund.   På Läkemedelsverket får du goda förutsättningar för balans i livet. Vi erbjuder dig bland annat flextid, förmånliga semestervillkor, friskvårdsbidrag samt friskvård på arbetstid. I den mån arbetsuppgifterna tillåter finns det möjlighet att delvis arbeta på distans efter överenskommelse med chef. Läs mer om de förmåner du får hos oss här: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss  Läkemedelsverket är beredskapsmyndighet, vilket innebär att vi genomför vissa bakgrundskontroller i samband med rekryteringar. Du kommer vid en eventuell intervju att behöva styrka din identitet samt uppvisa examensbevis och relevanta intyg. All tillsvidareanställd personal vid Läkemedelsverket är krigsplacerad inom myndigheten. Kontakt Du är välkommen att kontakta gruppcheferna Marianne Weisner eller Jenny Bjurström. Du kan även kontakta de fackliga företrädarna Jonas Walldén, Saco och Pia Wictor, ST. Vi finns alla på telefon 018-17 46 00 eller nås genom e-post fornamn.efternamn@lakemedelsverket.se. Mer om Läkemedelsverket Du tänker kanske inte så ofta på Läkemedelsverket, men vi kan lova att du möter oss i din vardag. Resultatet av det vi gör märks på apotek, sjukhus, hos veterinären och i ditt badrumsskåp. Vi ser nämligen till att du och alla andra i Sverige får tillgång till säkra och effektiva läkemedel och medicintekniska produkter, allt från plåster och graviditetstester till rollatorer och appar. Det gör vi genom att godkänna och ge tillstånd, övervaka och kontrollera och genom att informera och ge råd. Vi som arbetar på Läkemedelsverket är stolta över vårt viktiga samhällsuppdrag: att bidra till den svenska folk- och djurhälsan. Läs mer om vårt uppdrag och vad det innebär att arbeta på Läkemedelsverket här: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket Välkommen med din ansökan! Denna rekrytering sker helt genom Läkemedelsverkets försorg. Vi undanber oss därför telefonsamtal från rekryteringsföretag och annonsförsäljare.

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

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.

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.

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.

Junior Business Analyst: Japanese Language Specialist Job purpose: We are looking for a highly analytical and data-driven graduate with strong conversational Japanese language skills to join us in the business analysis team. The role will help you to develop a solid understanding of the pharmaceutical industry, strong quantitative and qualitative analytical skills, and to gain a unique insight into best practices across the industry, while supporting Japanese-language data and materials. As a member of the analysis team, you will have great visibility and exposure to senior directors in the company and the opportunity to take on a high level of responsibility for project delivery early-on in your career. You will be supported by an experienced analyst team through your development and training and be expected to collaborate and offer new insight within a close-knit team environment. Key Responsibilities: * Translating Japanese-language workbooks, data files, survey questions, and other project materials into English. * Translating English questions and materials into Japanese, ensuring accuracy and appropriate business and pharmaceutical context. * Supporting verbal communication and discussions in Japanese with the Japan Team where required, including clarification of data and project-related queries. * Managing multiple LIVE projects and their timelines to meet both internal and client’s deadlines. * Collaborating with Project leaders/Lead Analysts from Japan to interpret data and formulate action plans and recommendations for clients. * Analyzing data from multi-sources using quantitative and qualitative methods to derive insights. * Building and maintaining MS Excel databases from source data. * Produce high quality presentations and other deliverables for clients using PowerPoint. * Supporting members in the analysis team to meet client deadlines and drive development and efficiencies within the team both locally and on international projects. Essential Requirements: * JLPT N1, N2 (or equivalent practical fluency) required. * Strong working knowledge of Japanese, with hands-on experience using conversational (spoken) Japanese in a professional environment. * Ability to confidently translate both written and verbal Japanese content related to pharmaceutical and business analysis work * The ideal candidate having a Science/Analytics based degree in subjects with numerical emphasis (such as Chemistry, Physics, Mathematics, biotechnology, Engineering etc.) * High attention to detail, particularly when working with translated data and client materials. * Strong communication and multi-tasking skills to handle multiple projects with different stakeholders. * Advanced Level experience in using Excel and PowerPoint. * Proactive individual with drive and ambition, a strong work ethic to grow in a dynamic environment with good opportunities to help develop and further the business as a whole.   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.