- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... and skills: A minimum of 5 years regional medical affairs experience (eg, Regional Director Medical ...to medical affairs strategiesExperience in country/region medical affairs or clinical development (in IBD or… more
- Merck & Co. (Rahway, NJ)
- …solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...scientific resources, communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... the company as needed.ResponsibilitiesManages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.Seeks and incorporate regional and functional RA strategy into a global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides… 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 ... needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in...including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Position Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead ... in one or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of ... the Senior Director , GMA Oncology (Global Medical Affairs team...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with...strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs … more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive ... provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He… more
- Merck & Co. (Rahway, NJ)
- …the cross functional team including marketing and Product Development Teams (PDTs), (ex. clinical , CORE and medical affairs ), regional and country teams to ... Job DescriptionPosition Description: Director , Global Market Access, Immunology T he ...Development, Center for Observational and Real-World Evidence (CORE), Medical Affairs , Policy, Communications and regional and country teams. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for is provided to cross-functional teams including but not limited to product clinical development team(s), HEOR, PRA, medical affairs , manufacturing and PR. ... rare diseases and immune disorders. Job Summary: The Global Brand Associate Director is accountable for supporting the development, integration, and execution of all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-US labeling (outside… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Associate Director , Healthcare Quality Improvement is a role within the Global Professional Relations and Independent Medical ... Education (gPRIME) team of Global Medical and Scientific Affairs (GMSA) that is primarily responsible for supporting Our Company's collaboration with key external… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... high-quality, impactful customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions. The … more
