- 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
- Catalent (New York, NY)
- …Global Nutritional & Beauty Business Development Team reporting to the Regional Director Beauty Softgels North America, and responsible for managing new business ... 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. (Rahway, NJ)
- …them, approximately 85 scientists, people managers, chemical engineers, process safety , pilot plant operations and equipment development staff, and technicians. ... plant and commercial sites.- The organization, through the environmental and process safety engineering team, conducts process safety assessments for the entire… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product safety lead or part ... 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases 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… 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
- 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)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE). - Direct Project Support: ... 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
- 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
- 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)
- …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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:The RoleAs the Director of Software Engineering for Digital Assets APIs, you will be responsible for building and managing an engineering team who ... weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily...or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances:… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:The Role As the Director of Trading Architecture on the Architecture Team you will design and build software for our trading platform at Fidelity ... weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily...or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances:… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:We are currently sourcing for a Director , Trading Engineering for Crypto Trading to work in Jersey City, New Jersey. The Role The Director , ... weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily...or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances:… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:The RoleWe are looking for a highly skilled and expert Director , Cash Management Project Management to lead Product Support team. The ideal candidate ... rails & technology, project management and data analytics. The Director will be responsible for providing program management across...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
