- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by ... partnership with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA strategic plans and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Training and GMA Oncology TA/franchise in developing and reviewing global high- quality medical information and training materials/programs, ensuring accuracy and ... internal global medical education trainings to support regional medical affairs team needs.ResponsibilitiesEnsure high quality , scientifically sound Global… more
- Tris Pharma (Monmouth Junction, NJ)
- …Clinical Practices (GCPs). The role partners with Clinical Development, Clinical Operations, Medical Affairs and R&D Quality Assurance to develop and implement ... has an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title commensurate with… more
- Aequor (Thousand Oaks, CA)
- …validation protocol development and execution Experience with combination product / medical device quality systems verification Process equipment knowledge - ... to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with… more
- BioAgilytix (Boston, MA)
- …while you enable life-changing, life-saving therapeutics to the patients who need them.The Quality Engineer I is responsible for assisting in providing quality ... 21 CFR Part 11, Annex 11, Annex 15, CLIA and GAMPs- Perform the quality review of equipment SOPs, policies and validation master plans for equipment implementations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team based ... in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with responsibilities for providing … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionHealth Systems Oncology Medical Affairs Director, US Medical Affairs - NorCal, NV, AZThe Health Systems Oncology Medical Affairs Director (HSO ... across the full oncology product portfolio, clinical science, and quality management in a balanced and credible manner consistent...This role also serves as a resource for the Medical Affairs (MA) management team on strategic planning and… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director, Quality Assurance - Analytical,GMP has responsibility for the QA oversight ... approval of GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego,… more
- Merck & Co. (North Wales, PA)
- …big data to analyze the safety and efficacy claims of potential medical breakthroughs.Review the quality and reliability of clinical studies using ... deep scientific knowledge, statistical analysis and high- quality data to support decision making in clinical trials.Support statistical programming activities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... ready to make a difference? The Position The Principal Medical Writer is an expert in medical ...and questions arising during the writing process Assesses the quality of documents; provides findings and clear feedback to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , and other affiliates. ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, ... audit process.Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue audit… more
- Aequor (Thousand Oaks, CA)
- …combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical ... device industry. Evaluate documentation and operation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... ready to make a difference? The Position The Senior Medical Writer works closely with cross-functional project teams to...regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical… more
- Insmed Incorporated (San Diego, CA)
- …fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... for stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other functions to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Atlanta, GA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
