- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... advance our pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for… more
- Merck & Co. (Rahway, NJ)
- …time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior Director in the General Medicine ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs ...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external… 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. (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)
- …changing lives for a living. Are you ready to make a difference? The Position As Senior Medical Director for the novel modalities team, you will be part of ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Merck & Co. (Rahway, NJ)
- …medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …inclusion in our clinical portfolio. Relationship This role reports into the Director of Clinical Research Equity supporting the strategy across NACD. This ... Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs , medical affairs...to the needs of patients, sites, and caregivers With Director , serve as NACD SME on clinical … more
- Merck & Co. (North Wales, PA)
- …tactics and resources to address the opportunities.Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs ... Job DescriptionJob Description:The Associate Director , Marketing, HPV Scientific Strategy plays a critical...for a One Company approach.Collaborating with Program Leads, Medical Affairs and Global Expert Management & Strategy to plan… 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
- 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
- Merck & Co. (Rahway, NJ)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director ... oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of clinical … 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)
- …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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations within ... Job Description Position Description: Senior Specialist, Financial Planning & Analysis Our company's...support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, US East Coast ... Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non- clinical ,… more
