- 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)
- … development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate corporate ... investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Merck & Co. (Rahway, NJ)
- …and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products ... release from our company to external agencies and investigators.Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other ... under minimal supervision to solve complex project problems.Responsibilities- Protocol Development , Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization ... consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections...May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure high quality compound and multi-compound level deliverablesLead the development of global harmonization of programming processes supporting global ... retaining, developing, and managing employeesGuide career growth and provide development opportunity for statistical programmersManages contract statistical programming staff… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position… 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
- 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)
- …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)
- …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
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... plus 2 years of work experience in Pharma in job offered or as Product Manager/Global Delivery Lead. Also requires 2 years of leadership experience with/using the… 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
