- 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 ... vendors on expedited reports, as appropriate Participates in, and/or leads, key Drug Safety activities including, but not limited to: safety data review,… 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 ... 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
- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in ... through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The...and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support regulatory strategy for… 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 ... dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Role:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs.Guide organization on proper use of automated health care databases for drug safety -related Epidemiologic studies.Mentor junior staff in the design, ... The CSPV epidemiology group aims to provide strategy leadership in safety signal detection and evaluation, risk management, and post-marketing epidemiological … 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 ... global drug portfolio from the Research stage to post marketing/lifecycle...within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects ... point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy… 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
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they… 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
- Merck & Co. (Rahway, NJ)
- …for implementing technology products and associated services to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect ... support our organization's target and biomarker discovery, chemistry, Biologics, Vaccines, safety , and process and analytical R&D efforts. The ideal candidate will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant stakeholdersPartners with cross-functional leaders incl. from across RD, Safety , Tech/Supply and Commercial to coordinate SMEs and engagement activities ... and a working knowledge of global regulations and guidelines regarding drug development (incl. CMC), regulatory submissions and corresponding regulatory agency… 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... and reporting of clinical trials preferred- Knowledge of all phases of drug development, including early and late phase clinical development and submission… more
- Merck & Co. (Rahway, NJ)
- …drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and… more
- Merck & Co. (Rahway, NJ)
- …drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist)has primary responsibility for the planning and directing… more
