- Genmab (Plainsboro, NJ)
- …part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head ... solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of… more
- Genmab (Plainsboro, NJ)
- …be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton, New ... fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes, ... acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CMC and other appropriate groups… more
- Merck & Co. (Rahway, NJ)
- …focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including study ... analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre- clinical and translational work… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational ... in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Executive Director , Medical Affairs and will assist the Executive Director and Senior Director (where applicable) in managing multiple internal ... the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director...Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs… more
- Novo Nordisk Inc. (Omaha, NE)
- …for key strategic and priority Managed Markets accounts. Position reports to Field Director / Senior Field Director /Executive Director . Essential Functions ... & Outcomes Research (HEOR), as needed Field-based clinical support: Communicates clinical account strategies to NNI Senior Leadership Teams and Core Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategic Partner Engagements Team. Key internal NNI relationships include Medical Affairs therapy areas, other Clinical , Medical, Regulatory (CMR) functions, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Associate Director of Medical Data Strategy and Analytics plays a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations, clinical development, medical affairs CSPV and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... management or leading change management initiatives preferred- Prior experience in clinical development, Medical Affairs , or Global Marketing preferred-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting… more
- Merck & Co. (Fort Wayne, IN)
- …other field-based employees such as the Vaccine Key Customer Leader (VKCL), Vaccine Medical Affairs Leader (VMAL), Region Medical Director (RMD) as well as other ... Job DescriptionThe- Senior Vaccine Customer Representative (VCR) supports customers by... Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as… more
- Novo Nordisk Inc. (Indianapolis, IN)
- …trials in all stages of development. Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as… more
- Novo Nordisk Inc. (Little Rock, AR)
- …across the customer 's organizational structure. Relationships This position reports into a Director or Senior Director within the Area Market Access ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical / FDA Communications.Assists the ... Senior Director of Regulatory Affairs / Clinical Affairs in managing,...updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs /… more
- Abbott (Lake Forest, IL)
- …DESCRIPTION:: The position is within our ID BU and is member of the MCSO senior leadership team. This role has oversight and leadership over all of the medical and ... meet deliverables and hold self and team accountable. + Sr. Direct Medical Affairs activities, create and implement evidence plan, and KOL strategy for respiratory… more
