- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risk management tools and resources.Responsibilities- Strategic Advice and Support to Global Product Teams: 1) Provides expert, strategic advice on the creation and ... submission of RMPs and REMS. 2) Own and maintain the process for creating RMPs. 3) Provides expert, strategic advice on executing the requirements of RMP/REMS (including acquiring appropriate tools and competent vendors). 4) Guides and supports teams on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development, integration, and ... for is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs, manufacturing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Merck & Co. (North Wales, PA)
- …globe.Primary Responsibilities:Has a deep understanding of therapeutic area, including product knowledge, disease state management, emerging therapies, and the ... competitive landscape. Apply developed depth and breadth of disease, product and process expertise, and help solve unique and complex problems/inquiries specific to… more
- Merck & Co. (Rahway, NJ)
- …but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Required to keep informed of industry trends and newsworthy happenings, company product pipeline progress, and overall financial position of the Company in order ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... protocols.This position independently manages relationships with internal (CSPV, Regulatory, Clinical , Medical Affairs, HEOR and other stakeholders to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages team ... Project Teams including strategic development and execution of an integrated product development plan. This position may independently manage a lower complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead is responsible for the management of ... technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs to the sites of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... executes the pricing and contracting strategy for a key Novo Nordisk product category. Collaborates with internal and external stakeholders to leverage and implement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Merck & Co. (Rahway, NJ)
- …development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve ... The MACS Operations Specialist position will report to the Director , Engineering and will be a member of the...Specialist include the following:The Operations Specialist role at the Associate Specialist level will serve as a process team… more
- Insmed Incorporated (Bridgewater, NJ)
- …the development and communication of HEOR evidence to demonstrate the value of Insmed's product (s). The Associate Director will work closely with HEOR team ... in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... aspects for complex clinical trial(s) or indication product line. This role leads the protocol statistical section development, study setup, execution, analysis,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
