- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is ... The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... the product lifecycle process and develop risk mitigation strategies. Provide quality oversight and strategic quality advice to the CSPV and key business function… more
- Insmed Incorporated (Bridgewater, NJ)
- …manuscripts for publicationClosely partner with Research, Clinical teams, Bioanalytics, Regulatory , Project Management, and other R&D functionsProvide oversight ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development organization will… more
- Eisai, Inc (NJ)
- …components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Merck & Co. (North Wales, PA)
- …and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent ... reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at...quality and budget. A key focus will be the oversight of and interactions with CROs and other 3rd… more
- Eisai, Inc (Nutley, NJ)
- …components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and ... Proven knowledge of training and curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... of clinical outsourcing marketplace and industry trends.Participate in supplier oversight and governance meetings and lead processes improvement initiatives as… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development organization and ... has oversight over drug development aspects related to clinical pharmacology...communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth ... knowledge of regulatory authority's requirementsTypically has administrative responsibility for recruiting, retaining, developing, and managing employeesGuide career… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,...functions of Daiichi Sankyo. As a trusted partner, provide oversight of business demand to balance R&D IT portfolio… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure ... AI/ML deliverables- Contribute, with limited supervision, to documents submitted to regulatory or pricing authorities- Proactively identifies and manages risks in… more
- Merck & Co. (Rahway, NJ)
- …Modalities Drug Product Development teams, responsible for the scientific and technical oversight of our small molecule, large molecule, and mixed modalities drug ... regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements.Safety and Environment: Prioritize and maintain a safe work… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position may also collaborate with CROs (Clinical Research Organizations) and manage oversight . The position will partner with internal and external stakeholders to ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts ... most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the...preclinical through Phase 3 and 4.- CRO / Vendor Oversight : Participates in drafting request for proposal for CRO… more
