Sökresultat för "Pharmaceutical Industry"

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.

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

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

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.

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. Assignment Description We are looking for an experienced Automation Engineer What You Will Work On Develop and configure automation solutions for pharmaceutical manufacturing systems Design and implement control logic, sequences, phases, and interlocks Configure and optimize DeltaV or equivalent DCS automation platforms Develop HMI screens and operator interface solutions Configure alarm management and control strategies Integrate process equipment with control systems and higher-level applications Support batch control and recipe implementation Participate in FAT, SAT, commissioning, and system verification activities Troubleshoot automation systems during testing and startup Prepare and maintain automation documentation and technical specifications Support qualification and Computerized System Validation (CSV) activities Collaborate with process, validation, commissioning, and engineering teams Ensure compliance with GMP, GxP, and pharmaceutical quality standards Support system improvements and automation optimization throughout the project lifecycle What You Bring Experience as an Automation Engineer within the pharmaceutical industry or another GMP/GxP-regulated environment Strong hands-on experience with DeltaV or similar DCS/process automation platforms Experience configuring control logic, sequences, phases, interlocks, and alarm functions Experience developing HMI applications and operator interfaces Experience integrating process equipment with automation and supervisory systems Good understanding of GMP, GxP, and Computerized System Validation (CSV) Experience performing FAT, SAT, commissioning, startup, and automation verification Experience troubleshooting, testing, and documenting automation solutions in regulated environments Ability to work effectively with process, validation, and commissioning teams Strong analytical, troubleshooting, and communication skills

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. Assignment Description We are looking for an experienced Automation Lead What You Will Work On Lead the overall automation workstream for a major pharmaceutical investment project Define and drive the automation strategy and control philosophy Lead automation system design, implementation, testing, and deployment Design and implement DeltaV automation architecture and solutions Develop and manage batch automation systems and recipe implementation Coordinate system integration between equipment, automation platforms, and surrounding systems Design and review sequence logic, interlocks, alarm management, HMI solutions, and operator interfaces Lead technical design reviews and make key technical decisions Coordinate automation engineers and cross-functional technical teams Collaborate closely with process, validation, commissioning, and production teams Plan and oversee FAT, SAT, automation testing, and verification activities Ensure compliance with GMP, GxP, and Computerized System Validation (CSV) requirements Support commissioning, qualification, and operational readiness of automation systems Prepare and maintain automation documentation, functional specifications, and control strategies What You Bring Several years of experience leading automation projects within the pharmaceutical industry or other GMP/GxP-regulated environments Deep expertise in process automation, batch systems, and control strategies Extensive hands-on experience with DeltaV architecture, design, and implementation Strong experience with batch control, recipe implementation, and system integration Solid understanding of sequence logic, interlocks, alarm management, HMI design, and operator interfaces Experience integrating equipment with automation and surrounding systems Strong knowledge of GMP, GxP, and Computerized System Validation (CSV) Experience leading technical design reviews and making architecture decisions Proven ability to lead automation engineers and coordinate cross-functional technical teams Experience planning and executing FAT, SAT, automation testing, and verification Excellent leadership, communication, and stakeholder management skills

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. Assignment Description We are looking for an experienced Validation Lead What You Will Work On Define and lead the overall validation strategy for the project Develop verification and qualification approaches for technical systems and equipment Lead validation activities across project phases Perform and coordinate risk assessments related to validation Ensure full compliance with GMP and GxP regulations Lead Computerized System Validation (CSV) activities Validate computerized systems, manufacturing processes, and technical equipment Support validation of DeltaV or similar automation platforms Develop and maintain traceability matrices Coordinate qualification activities including IQ, OQ, and related verification processes Manage validation documentation and compliance deliverables Lead deviation investigations, CAPA activities, and corrective actions Collaborate with automation, process, commissioning, engineering, and quality teams Coordinate validation activities across multiple stakeholders Ensure successful delivery of validation objectives within project timelines What You Bring Several years of validation experience within the pharmaceutical industry Strong knowledge of GMP and GxP regulatory requirements Extensive experience with Computerized System Validation (CSV) Experience validating computerized systems, manufacturing processes, and technical equipment Practical experience with DeltaV or similar automation platforms in regulated environments Experience developing validation strategies and verification approaches Experience conducting risk assessments and qualification planning Experience with traceability matrices and requirements management Experience handling deviations, CAPA, and validation documentation Strong leadership, coordination, and stakeholder management skills Excellent communication and technical documentation skills

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. Assignment Description We are looking for an experienced Commissioning Lead What You Will Work On Lead commissioning and installation activities throughout the project lifecycle Plan, coordinate, and execute commissioning activities for technical systems and equipment Manage the transition from installation to operational startup Coordinate activities across process, automation, validation, production, and installation teams Support commissioning of DeltaV or similar automation platforms Plan and execute FAT, SAT, functional testing, and integrated system testing Manage punch lists and commissioning close-out activities Conduct readiness reviews before startup and handover Coordinate system handover to operations and qualification teams Lead contractors and coordinate on-site commissioning activities Ensure compliance with GMP requirements and project quality standards Manage project schedules, risks, and commissioning deliverables Collaborate with cross-functional engineering and project teams Drive safe and efficient startup of manufacturing systems and facilities What You Bring Several years of experience leading commissioning or installation activities within the pharmaceutical industry Experience commissioning systems in GMP-regulated environments Strong experience coordinating process, automation, validation, production, and installation teams Hands-on experience with DeltaV or similar automation platforms Experience planning and executing FAT, SAT, functional testing, and integrated testing Experience managing punch lists, readiness reviews, and system handovers Experience leading contractors and coordinating site activities Strong understanding of project management, risk management, and scheduling Excellent stakeholder management and leadership skills Strong communication and technical documentation abilities

We invite you to come grow with us. Research Partnership (part of Inizio Ignite) is one of the world's largest pharma market research and consulting agencies with over 250 researchers, consultants, project managers and support staff. Our teams are located across the globe, in Europe (London, Lyon), North America (New York, Philadelphia, San Francisco), India (New Delhi), and Singapore. As individuals with diverse backgrounds, as a team with shared values, as professionals ready to reimagine health and life sciences—you can grow with us at a place that: * Makes a difference to human health * Shares values and celebrates progress * Puts people at the center of everything   About the team:  Our custom research team partners with global pharmaceutical and biotech clients to enable them to solve marketing, brand, advertising and communications problems through a mixture of innovative qualitative and quantitative market research techniques. You will be empowered to develop broad expertise across the healthcare landscape, and will have the opportunity to work with a wide range of expert senior researchers and gain exposure to the full suite of research tools and techniques covered by the team. Our studies are typically multi-market, encompassing Europe, North America and Emerging Markets. We believe that exposure to a wide range of healthcare systems – and different cultural approaches to healthcare – helps our researchers to offer the most impactful, commercially-relevant insights to our clients.   Your primary role: * Lead projects and project teams, be the main point of contact with the client and write and give client presentations * Line management of multiple individuals with the responsibility of conducting appraisals, pay reviews, monitoring of performance, personal development, training of staff, recruitment and developing and implementing internal company procedures * Engage in business development and sales initiatives * Write proposals to win new business, consider timescales and calculate the research cost alongside VPs and operations * Involvement in talent acquisition and assessing potential new staff    About You…  Your skills and experience: * At least 7 years of experience with qualitative custom primary market research projects * Experience in the life sciences sector * Extensive expertise in qualitative market research methodologies, including advanced moderation techniques, delivering actionable insights across diverse markets * Proven ability to mentor and develop both junior and senior team members, fostering deep expertise in qualitative research practices and pharmaceutical industry knowledge * Highly skilled in moderating in-depth interviews and focus groups, both via telephone and in-person, ensuring rich, meaningful data collection and analysis * Strong client engagement and relationship management skills * Proven project supervision skills * Appreciation of marketing/client-side issues, knowledge and understanding of client issues * Self-motivated and able to work independently * Excellent communication skills, both verbal and written * Ability to multitask under pressure and meet tight deadlines   Ideal profile: * You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach * You demonstrate a high level of accuracy and attention to detail, as well as strengths in organization and prioritization * You are a collaborative team player who works well with colleagues * You communicate ideas and issues in an effective, straightforward fashion * You are highly motivated and want to seize opportunities to develop new skills and progress your career   Life at Research Partnership: We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide: * A relaxed and friendly working environment * Social events - including a summer day out and end of year party, along with regular social events after office hours * Fundraising and charity events – we support Forever Angels, a children's charity whose aim is to care for abandoned babies in Tanzania, Africa    Employee Benefits: * A comprehensive training and development program * Opportunities for internal advancement * Annual salary and promotion review * Paid time off, up to 25 days including your birthday * 401(k) plan with employee match * Medical/vision/dental/prescription insurance plans, including heath savings and flexible spending accounts * Company paid life insurance * Short term/long term disability * Commuter reimbursement accounts * Employee assistance program    Our Pledge At Research Partnership, 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 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, colour, religion or belief, gender, gender identity, age, national origin, marital status, military veteran status, genetic information, sexual orientation and physical or mental disability. Inizio Ignite, Research Partnership  Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward.     Further information: This is a full-time role. You can choose to work out of our NYC, SF or Yardley, PA (Philadelphia) office for as many days out of the week as you’d like or work remotely. #LI-ND1 #LI-Hyrbid   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 $125,000—$160,000 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.

Join us as a Global Study Associate Director (GSAD) in our BioPharmaceuticals Clinical Operations team at AstraZeneca's dynamic R&D site in Gothenburg (Sweden). This role is pivotal in the delivery of clinical studies, providing direction and guidance to a cross-functional study team within the Cardiovascular, Renal and Metabolism (CVRM) therapy area. As the main liaison between the study team and the Clinical Program Team (CPT), you will be accountable for the delivery of a study according to agreed timelines, budget, and quality standards. Accountabilities As a GSAD, you will lead and provide guidance to a cross-functional study team, ensuring the clinical study progresses as planned. You will be responsible for developing essential study level documents, overseeing external service providers, and ensuring all systems used at a study-level are current and accurate. You will also oversee study level performance against agreed upon plans, milestones, and key performance indicators. Additionally, you will be responsible for study budget re-forecasting and management throughout the study lifecycle. Essential Skills/Experience University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research Relevant clinical experience in the pharmaceutical industry, including project management experience Extensive study management experience Extensive knowledge of ICH-GCP, clinical research regulatory requirements Demonstrated solid project management skills Strong abilities in team leadership with experience from cross-functional leadership of a clinical study or part of a clinical study Excellent communication and interpersonal skills Strong strategic and critical thinking abilities Ability to manage competing priorities Desirable Skills/Experience Advanced degree, master's level education (or higher) Project management certification Proven project management experience on a global level Experience in all phases of a clinical study lifecycle At AstraZeneca, we are driven by our passion for science and our commitment to making a difference. We fuse data and technology with the latest scientific innovations to achieve breakthroughs that have never been done before. Our inclusive environment allows us to work seamlessly as one, leveraging our diverse global knowledge to create the greatest impact on disease. We are constantly advancing our scientific knowledge to shape the future of healthcare and improve patient access to life-changing medicines. If you are ready to make a significant impact on patients' lives and push the boundaries of science, apply now! We welcome your application by Aug 16th, 2026.

At Intervacc, we are pioneering the next generation of veterinary vaccines through our proprietary technology platform. Rooted in research from the Karolinska Institute (KI) and the Swedish University of Agricultural Sciences (SLU), our mission is to reduce the impact of bacterial infections in animals through innovative, effective, and safe vaccines. Our first proprietary product — a vaccine against strangles, a serious streptococcal infection in horses— is now available in several European markets. This is just the beginning. We are expanding our reach into new territories and broadening our product portfolio. We have an exciting new opportunity for an experienced CMC Lead who will be responsible for the manufacturing and testing for the company’s marketed products, as well as the CMC-strategy for development of new vaccine products. The CMC Lead will have a central role in providing scientific guidance, support, and expertise for all CMC activities including commercial products and product under development. You will work with products in different markets to fulfill a key role within our dedicated, friendly and experienced team. If this sounds interesting to you – come join us! Intervacc AB is headquartered in Stockholm Sweden and is listed on the Swedish Nasdaq First North Growth Market. The position is full-time, and we welcome your application today! Key responsibilities As a CMC Lead, you will provide CMC strategy and expertise for our development and marketed products to ensure the company’s products are developed, manufactured, tested and maintained in compliance with global regulatory expectations, requirements and guidance. Duties and responsibilities include: Responsibility of delivering CMC-parts of development projects, launch projects as well as projects/products in commercial phase Developing CMC-strategies and ensuring oversight and planning of work performed at CROs/CMOs related to development, analytical testing and manufacturing of products Monitor KPIs and ensure timely delivery of data to support development, manufacturing and release Being responsible and promote using modern processing analytical principles such as Quality by Design, risk-based method development and data-driven decision making. Working with other internal functions as well as external suppliers and partners to ensure CMC-deliverables and resolve arising issues Participating in budget planning and monitoring Ensure compliance with global regulatory requirements and support regulatory inspections and audits Skills and Competencies The suitable candidate has the following qualifications: Formal academic degree level (MSc., Ph.D) in a science-related subject e.g. pharmacy, biology or chemistry Significant experience (more than 7-10 years) in development, manufacturing and analytical testing of biologics or biotechnology-derived products e.g. vaccines from the pharmaceutical industry Significant knowledge of the drug development and manufacturing process for biologics (including upstream and downstream processes and analytical methods) Expert knowledge in analytical and/or process development for biologics Understanding of supply planning and supplier management Knowledge of current regulatory CMC requirements, and solid knowledge in understanding of regulations and guidance for the manufacturing of biotechnology products Excellent communication and documentation skills in English are required The successful candidate for this position will be someone who: Has a solid scientific background with significant experience in processing and analytical testing of biotechnology products in combination with project management skills Is analytical, solution-oriented with a strong personal drive Is structured and organized Has a good eye for detail and a thorough approach to work Is a proactive, flexible, motivated and ambitious team player with ability to drive change If you are ready to bring your expertise within the CMC area for biologics, we are ready to offer you an excellent career opportunity at an innovative company with an exciting journey ahead! About Intervacc: Intervacc is an innovative Swedish biotechnology company that develops and markets modern, effective, and safe vaccines against bacterial infections affecting animals. Over the past decade, advances in molecular biology techniques have significantly enhanced our ability to investigate the genomes of pathogenic bacteria. Building on our research foundations at the Karolinska Institute (KI) and the Swedish University of Agricultural Sciences (SLU), we have developed a technology platform for a new generation of vaccines. Our first proprietary vaccine, a vaccine against the streptococcal infection strangles, which affects horses—is now available in several European markets. The Intervacc share (STO: IVACC) is listed on the NASDAQ First North Growth Market and our headquarter is in Stockholm, Sweden. You can find more information about Intervacc at www.intervacc.se For more information about this position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

Academic Resource is searching for a Direct Sourcing Lead / Planner to Life Science company in Uppsala. The job is a fulltime consultancy assignment, for 6 months initially with opportunities for extension. Location in Uppsala. Start as soon as possible. Description of the role / job tasks: The Direct Sourcing Lead is accountable for strategic and operational sourcing execution with full ownership for assigned commodities and suppliers. • Lead the development and execution of sourcing strategies for assigned commodities and suppliers, delivering competitive advantage through supplier selection, development, consolidation, and performance optimization. • Manage the full procurement lifecycle, including RFQs, negotiations, contracting, and purchase execution for assigned category. • Maintain full accountability for buy execution, meeting deflation, cost reduction, and KPI targets. • Drive supplier performance, optimization, and continuous improvement. • Perform detailed cost and manufacturing process analysis to ensure highest quality at the lowest total cost of ownership. • Analyze and apply structured sourcing tools for risk and spend optimization to deliver and improve sourcing targets • Collaborate closely with key business stakeholders to identify, qualify, and onboard suppliers and to ensure sourced material and services meet the needs of the business. • Building deep relationships with Strategic Suppliers driving early supplier engagement into NPI/NPD process, and long-term partnership for wing-to-wing product lifecycle. • Driving improvements in sourcing processes including escalations due to delivery/quality issues, invoicing/payables issues, and database management • Monitor global markets and regulatory trends and developments, become a commodity expert for the assigned commodities and proactively adapting sourcing strategies to mitigate risk and ensure long term supply security. • Working with businesses and suppliers to manage and track implementation of supply agreements, communicating to Business General Managers and other senior staff, obtain sign-off for projects. Requirements for the role: • Bachelor’s degree in Chemistry, Chemical Engineering, Chemical Technology or Engineering, Materials Science, Mechanical Engineering, Industrial Engineering, Packaging Engineering or other technical discipline OR Bachelor’s degree plus 5+ years of experience in Strategic Sourcing / Direct Procurement OR 9+ years of experience in sourcing or procurement if no technical degree. • 8-9 years of experience in direct procurement, strategic sourcing, GMP, regulated chemical supply markets, regulatory requirements, and sourcing best practices. • Life Sciences, Biotech, or Pharmaceutical industry experience preferred. • Excellent negotiations skills and analytical skills with the ability to handle and develop supplier relationships • Ability to energize, develop and establish rapport at all levels within an organization • Shown ability to execute and deliver on commitments • Experience implementing a compliant supply chain, supply agreement execution experience • Strong business/financial acumen, proficient in leading and setting direction, including demonstrated ability to motivate, influence and inspire change globally and across all levels of the organization. • High level of analytical skills and experience in driving global tender processes • Willingness to travel domestically and internationally • Fluent in English, both spoken and written. • Experience with ERP systems (e.g., SAP, Oracle) and procurement analytics tools • Excellent skills in Excel and Powerpoint Nice if you also have: • Master’s degree in Management or Engineering (MBA, MS, MTech) • Procurement or Supply Chain certifications (e.g. CIPS, CPSM, PMP) • Swedish spoken and written. • Greenbelt certification preferred. Soft skills: • Self-motivated and able to work independently and within the team • Excellent negotiation, communication, and cross-functional collaboration skills About Academic Resource: Academic Resource is the recruitment and staffing company for academics with experience. We have extensive experience in Leasing, Recruitment and Interim Management in the service sector. Our business areas are Life Science, Economics & Finance, and HR. We operate in the service sector and mainly in Stockholm & Uppsala. As a consultant at Academic Resource you are offered: • Benefits such as occupational pension, health care allowance and parental pay. • An authorized staffing company, which means much greater security, as you are covered by the terms of the collective agreement for, for example, salary, insurance, pension and vacation. • A dedicated consultant manager who is available and keeps in constant contact with you and the client companies throughout your employment, who ensures that you enjoy and develop in your workplace! • Opportunity to develop through learning on the job as well as in varied roles at interesting client companies. Application: Selection and interviews will be ongoing. The position may be filled before the last day of application therefore we recommend that you apply as soon as possible. Submit your CV written in English. Mark your application with reference number: CSL0426 Do you have any questions? Do not hesitate to contact us by email at: rekrytering.lifescience@academicresource.se Please note that we do not accept applications via email. we take you further

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role you will get the opportunity to work with committed colleagues in a collaborative team. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the way we work with our outsourced manufacturing activities. We are looking for an experienced Senior Outsourcing Manager to join our Manufacturing Operations team. In this role, you will be responsible for driving outsourcing programs for injectable pharmaceutical products to Contract Manufacturing Organizations (CMOs), with a particular focus on late-stage development projects. As Senior Outsourcing Manager, you will serve as the primary interface between Camurus and external manufacturing partners. This is a true Project Management role where you will ensure successful project execution from technology transfer through start of commercial production. You will work closely with internal stakeholders and external partners to secure reliable, compliant, and efficient delivery of the project. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Develop and manage project plans, timelines, and milestones for technology transfer, process development, process validation, and manufacturing readiness activities together with CMO partners. · Drive day-to-day collaboration with CMOs and ensure agreed deliverables, timelines, and performance targets are achieved. · Lead operational meetings and steering committee meetings with external manufacturing partners. · Identify risks and issues proactively and drive mitigation and resolution activities together with internal and external stakeholders. · Coordinate and manage changes with CMOs, ensuring proper documentation, implementation, and alignment with project plans and contractual commitments. · Collaborate closely with internal Camurus functions such as Quality, R&D, Regulatory Affairs and Supply Chain to ensure successful project execution. · Ensure manufacturing activities are conducted in accordance with applicable GMP requirements and regulatory expectations. · Support continuous improvement initiatives related to outsourcing, external manufacturing operations, and CMO performance. Candidate profile We are looking for a professional with extensive experience from pharmaceutical manufacturing operations including outsourcing and CMO management. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have a solid understanding of GMP-regulated manufacturing environments and a proven track record of managing outsourcing programs and external manufacturing partners within the pharmaceutical or biotech industry. Experience from late-stage development, technology transfer and commercial manufacturing is highly valued. Experience from injectable products and combination products is considered a strong merit. As a person, you are structured, collaborative, and communicative, with a proven ability to drive complex projects and build strong relationships across multiple stakeholders. You combine a proactive and results-oriented mindset with a pragmatic and hands-on approach, while maintaining a humble and low-prestige attitude. Fluency in spoken and written and English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!

Join CTC - where ambition is high and one of the goals is to strengthen the Swedish infrastructure in the Life Sciences! We are growing and are now looking for an additional Medical Writer who wants to contribute to CTC’s continued journey. Are you an experienced Medical Writer (MW) who wants to use your expertise to drive CTC’s development? Then this is the opportunity for you! As a Medical Writer at CTC, you will be part of a team of four other MWs responsible for writing and quality-checking regulatory documents, primarily clinical study protocols and reports. The work alternates between individual tasks and teamwork. You will be part of various study-specific project teams responsible for initiating and managing clinical projects until the delivery of study results. These cross-functional project teams include professionals such as project managers, medical and scientific advisors, research nurses, doctors, statisticians, and more. Main responsibilities: To write clinical study protocols and clinical study reports in accordance with ICH E6, ICH E3, and/or ISO 14155, and coordinate the development and quality control processes of these documents, both internally and with our clients. To write other regulatory documents and texts such as summary of results, narratives, substantial amendments and responses to authorities. To coordinate and lead meetings, both internally and externally, and act as a point of contact for clients. To serve as a mentor to colleagues. Other tasks such as medical coding, writing abstracts and scientific articles, writing assignments related to safety reporting, and writing marketing documents may also be required. We are looking for a driven and experienced Medical Writer who truly enjoys writing and formulating scientific texts. To succeed in this role, you need to have the ability to quickly and efficiently interpret, summarize, and present large amounts of data. We require you to have at least 3 years of experience in medical writing, drug development, and clinical trials. Previous experience in consultancy work and an understanding of the customer perspective are also valued. As a person, you are communicative and enjoy collaborating with experts in various fields. You are flexible, works independently, and deliver within agreed timelines. CTC’s core values: Innovation, Community, Respect, Commitment, and Professionalism resonate with you. Required qualifications MSc in the life sciences field. At least 3 years of experience in medical writing, drug development, and clinical trials. Experience in leading meetings and coordinating complex and parallel deliveries within agreed timelines. Proficiency in using the Microsoft Office suite, especially Microsoft Word. Excellent ability to express yourself grammatically correctly and clearly in English, both spoken and written. Good knowledge of the Swedish language (spoken and written). Preferred qualifications A PhD in the life sciences field. Experience with Phase 2-3 trials. Experience with medical devices and/or advanced therapy medicinal products (ATMP), as well as knowledge of regulatory requirements related to these areas. Experience in writing eCTD module 2; Clinical and Non-Clinical overview/summary, Investigator’s Brochures (IBs), Annual Safety Reports (ASRs). At CTC, you will be covered by a collective agreement and offered benefits such as flexible working hours, wellness allowance, and generous vacation terms. You will have the opportunity to work in a knowledge-intensive environment in a company with short decision-making paths, with good professional development opportunities. The position is located at our office in Uppsala (hybrid work is possible). Full time (40 hours per week). If you have questions, contact Marit Wangheim (Director Medical Writing) marit.wangheim@ctc-ab.se Please submit your application no later than 17 August 2026. CTC Clinical Trial Consultants AB is a Clinical Research Organization (CRO) with operations in Uppsala, Stockholm, Linköping, and Gothenburg. As a CRO, we conduct clinical trials and investigations on behalf of the pharmaceutical and medtech industry and academic institutions. We offer a comprehensive full-service solution that includes all the services, activities, and deliverables required to successfully conduct a clinical trial— bringing new pharmaceuticals and products to patients. We currently conduct clinical studies across all phases of development, from Phase 0 through Phase IV. Most of our studies are carried out at our own research clinics, although we also collaborate with external clinical sites. We employ approximately 125 people, around half of whom work in clinical roles. Our headquarters are located in Uppsala.

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

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