- Tris Pharma (Monmouth Junction, NJ)
- …team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety . The Director, Drug Safety is responsible for ... vendors on expedited reports, as appropriate Participates in, and/or leads, key Drug Safety activities including, but not limited to: safety data review,… more
- Eisai, Inc (Nutley, NJ)
- …authorities.Interface with other Eisai Departments and affiliates for dissemination of Drug Safety information, including training and orientation programs for ... for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Insmed Incorporated (Bridgewater, NJ)
- …Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent ... and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. ResponsibilitiesAdditional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety , data, CMC, IP, patient selection, market ... acumen.Providing best practices to DS's overall development strategy and drug development goals. Influencing their adoption and facilitating cross-functional… more
- Taiho Oncology (New York, NY)
- …responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Uses medical affairs plans to develop and ... align the field tactical plan for MSL geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg, medical territory, engagement plans/ SL/HCP Rosters,. Training/Education Resource: Develops,… more
- Taiho Oncology (TX)
- …responsibilities as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and ... align the tactical plan for MSL geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned territory, eg medical territory plan Training/Education Resource: Develop, maintain and demonstrate scientific expertise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety , will be a product safety lead or part of a product ... safety team, and be responsible for overall product safety strategy or specific areas of safety ...to strategically manage benefit-risk throughout the lifecycle of the drug . Specific responsibilities will vary depending on the stage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded 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 global drug … more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... of our small molecule, large molecule, and mixed modalities drug product formulation design, process development, and innovation to establish and maintain a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently ... with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents… more
- Merck & Co. (Rahway, NJ)
- …facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and ... is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewOverview The 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
- Merck & Co. (Rahway, NJ)
- …single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary activities include, but are not ... prepare our company's teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak… more
- Merck & Co. (Rahway, NJ)
- …Position Description: Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the ... supports statistical programming activities for multiple and/or late stage drug clinical development projects.- Accountability predominantly includes the development… more
- Catalent (Manassas, VA)
- …routine maintenance and upkeep of the company vehicle to include a daily visual safety inspection and proper fuel levels; Loads and unloads materials onto or from ... system (WMS) system preferred Ability to observe and follow safety procedures; Ability to ensure that all Standard Operating...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Catalent (St. Petersburg, FL)
- …Petersburg State : FL JOB DESCRIPTION:Perform routine test methods in support of drug substance and drug product sample testing;Analyze data, documenting results ... rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Merck & Co. (North Wales, PA)
- …drugs;-Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... of generating early clinical development plan and Investigational New Drug applications;-Developing clinical development strategies for investigational or marketed… more
