- 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
- Tris Pharma (Monmouth Junction, NJ)
- …the Pain therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior Medical Director ... Pain. The incumbent is responsible for leading development/delivery and execution oversight of the Pain clinical development strategy and clinical development plans.… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... and overseeing development strategies and providing leadership, direction and oversight of the clinical development function and company clinical programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… 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)
- …Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight of information ... clinical documents (eg protocol, study report, NDA documents), providing medical oversight for investigational sites, doing research, and participating in and… 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
- 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 (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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding ... outsourcing (eg, study startup, study conduct, study closeout, and reporting).Provides oversight to CRO pertaining to medical coding, coding standards, and coding… 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
- 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
- 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
- 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
- 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)
- …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
- 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
