- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to case processing activities. Relationships Reports to the Executive Director , NAO Patient Safety with cross-functional working relationships within ... and evaluation of all technical complaints and adverse events reported to NNI Patient Safety for marketed products. Serves as the lead of the Case Processing Group.… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …guidance to the Medical Safety Leads on decisions that have significant drug safety implications, including safety signal detection activities of ... (CROs). Participates in the evaluation, monitoring, and oversight of strategic drug safety partners, CROs, professional consultants, and /or contractors… 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
- 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
- Merck & Co. (Rahway, NJ)
- …diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... developing, and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice… 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
- Integrated Resources, Inc (Cambridge, MA)
- …MA Duration: 8+ Months Job Description: Duties: . Reporting to the Associate Director , Drug Safety and Pharmacovigilance Compliance and Operations, you ... will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs. You will… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Product Line Technical Lead, Experimental Design and Execution We are seeking an energetic and collaborative person to ... management in our organization and combine this with your knowledge of drug discovery and development to inspire the cross-functional product organization to deliver… 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
- 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)
- …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
- 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)
- …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
