- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety ... or appropriate vendors on expedited reports, as appropriate Participates in, and/or leads, key Drug Safety activities including, but not limited to: safety … more
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... methodology, we collaborate to discover and develop the next medical breakthrough. Our company's success is backed by ethical...scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the day-to-day direction ... to Medical Safety Team to ensure business needs...to Medical Safety Team to ensure business needs and priority tasks...strategic consultation, and guidance to the Medical Safety Leads on decisions that have significant drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...safety team, and be responsible for overall product safety strategy or specific areas of safety … more
- Tris Pharma (Monmouth Junction, NJ)
- …Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, Medical Writers, ... immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...global drug portfolio from the Research stage to post marketing/lifecycle… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors ... opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... relevant stakeholdersPartners with cross-functional leaders incl. from across RD, Safety , Tech/Supply and Commercial to coordinate SMEs and engagement activities… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group to...quality oversight of manufacturing operations and the release of drug substance and/or final drug product to… more
- Insmed Incorporated (Bridgewater, NJ)
- …to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical /Clinical Departments. The ... and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. ResponsibilitiesAdditional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality team based in Raritan, NJ. Role ... Overview The Director of Quality Operations , CAR-T is responsible for...include Disposition activities , including incoming materials and final drug product, QA shop floor oversight of manufacturing operations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external stakeholders to ensure consistent, accurate communication of medical and drug information. Relationships Reports to a Director level employee in ... in NNI. Key relationships include Medical & Scientific Affairs, Field Medical Affairs, Product Safety , Customer Care, Sales, and Marketing. Essential… more
- Catalent (CA)
- …Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an Account Director , Pharmaceutical Softgel and Late-Stage Oral Solids. This position will be ... covering either a specific geography or a portfolio of accounts. As an Account Director , you will join our dynamic Business Development Team and your primary role is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Nordisk P&L goals for assigned products. Collaborate with marketing, Global Insights, medical and key cross-functional teams in developing a strategic vision via… more
