- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the Executive Director , NAO Patient Safety with cross-functional working relationships within Medical , Regulatory, Marketing, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...technical complaints and adverse events reported to NNI Patient Safety for marketed products. Serves as the lead of… more
- 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. (North Wales, PA)
- …the Director may be responsible for: Providing scientific and medical leadership for strategic alliances and Co-partnership opportunities.-Supporting the team in ... drugs;-Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical… 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Director , Quality Assurance 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 ... teams. This position requires significant understanding of clinical research for drug development, from hypothesis formulation to subject enrollment, use of… 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
- 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 developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product… 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
- ContinueCARE Hospital at Hendrick Medical Center (Abilene, TX)
- The Director of Quality Management will establish, implement, facilitate and coordinate the ongoing, hospital-wide Quality assurance compliance with CIHQ in ... as hospital Compliance Officer and Risk Manager Monitor compliance with the safety plans within the Environment of Care Management Program Collects data, prepares… more
- Piedmont Airlines, Inc (Charlotte, NC)
- …Piedmont is seeking a motivated, reliable leader to join our team as a Director , Ground Safety in our Safety Department. The primary responsibility ... ground handling management to ensure and enhance compliance with safety and security procedures. The Director , Ground...clear driving record, 10-year Criminal History Records Check, and drug screen as required. We also require proof of… more
- Health Services Advisory Group (Atlanta, GA)
- …to) a wide array of different healthcare data types: medical and prescription drug claims and encounterseligibilitydemographicsurveymedical recordregistryvital ... a leadership position healthcare analytics and data science as an Associate Director , Program Evaluations in HSAG's Data Science & Advanced Analytics (DSAA)… more
