- Merck & Co. (Rahway, NJ)
- …to a diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... mindset, and collaboration with various partners and stakeholders in development is expected.The Director will report to...step across boundaries, and implement novel innovations during drug product development to enable the best science… more
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation and ... profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical...assigned therapeutic area to provide strategic input for the development of product strategies and liaises with… more
- Eisai, Inc (Nutley, NJ)
- …knowledge in assigned therapeutic area to provide strategic input for the development of product strategies and liaise with external stakeholders to ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy,… more
- Tris Pharma (Monmouth Junction, NJ)
- …is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...and PV issues Provides input and expertise to aggregate safety reports (ie, development safety … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, ... collaborative scientific community that inspires innovation and enables speed of new product development from clinical research to commercialization of robustly… 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 ...may function as a key member of the Global Product Team in collaboration with Clinical Development ,… more
- Insmed Incorporated (Bridgewater, NJ)
- …communication of safety information for Insmed's portfolio of products in development and on the market.Accountable for the delivery of high quality and timely ... and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs). Leads the Safety Review Team(s) for assigned products and development compounds, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety is diligently considered prior to selecting promising candidates (DP0), allowing product safety leaders (PSLs) and global project teams (GPTs) to enact ... 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… more
- Merck & Co. (Rahway, NJ)
- …that help everyone to be more productive and enable innovation.The Research and Development Sciences (RaDS) value team in Our Company's R&D IT brings together ... product management, engineering, and data science expertise to enable...and associated services to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with… more
- Merck & Co. (North Wales, PA)
- …and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for ... by regulatory agencies for multiple indications simultaneously.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and ... areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring ... the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a team of supply chain professionals, providing coaching, feedback, and career development opportunities. Relationships Reports to the Executive Director , North ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming… 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 ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to epidemiology strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, ... study design, preparation of data for statistical analysis to obtain background rates) for development of safety documents (eg, RMP), support SMTs, SERM or other… 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...and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients… more
- Merck & Co. (North Wales, PA)
- …global scientific content development , review of standard response document (SRD) on product safety and efficacy, and when required, interact with HCPs to ... approach.-Review all medical information resources and standard response documents containing product safety , tolerability and efficacy data. Interact with HCPs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development strategies for program/s under IST; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and ... for Phase 3 registrational study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position… more
