- Genmab (NJ)
- …development programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development , approval and ... Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (eg, Core Data… more
- Merck & Co. (Rahway, NJ)
- …our ophthalmology products. In this role, the Director will lead the development and execution of global market access strategies, payer value proposition, ... appropriate time of product life cycle. Lead the development , communication and approval process of Global ...click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Pediatrics will focus on driving strategy, development , and ... the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of... multiple programs that are in various stages of development therefore requiring someone who has late vaccine clinical… more
- Merck & Co. (Rahway, NJ)
- …Document Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development , High Performance ... Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research… more
- Merck & Co. (Rahway, NJ)
- …quality and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, ... Device Technical and Engineering Leaders, assisting them in navigating their development programs.Primary Responsibilities: Lead and set direction for the device… more
- Eisai, Inc (Nutley, NJ)
- …Functions Provide global regulatory leadership in support of the global development , registration, and life-cycle management of products under ... The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EU as well as UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide ... with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and groups throughout the US organization, Clinical development , Research & Early Development , other affiliates, and the Global HQ teams. We are looking for ... and initiatives relative to congresses, speaker programs as well as market development . This role is responsible for developing and implementing effective congress… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development , validation, implementation, and integration of GxP-regulated systems across the organization. This ... global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and groups throughout the US organization, Clinical development , Research & Early Development , other affiliates, and the Global HQ teams. We are looking for ... than ever before. The Position The Thought Leader Liaison Lead plays a pivotal role leading a team of...trends, KOL perspectives, and patient needs to inform strategy development Contribute customer and market insights to the marketing… more
- Merck & Co. (Rahway, NJ)
- …regulatory, company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development , design controls for the assigned projects. Lead ... device development or design controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and groups throughout the US organization, Clinical development , Research & Early Development , other affiliates, and the Global HQ teams. We are looking for ... more patients than ever before. The Position The Rare Disease Marketing Operations Lead is responsible for assisting the Rare Disease Commercial Strategy & Marketing… more
- Insmed Incorporated (San Diego, CA)
- …solutions to enable rapid process development . May act as a Process Development Team representative as an Analytical Lead for a drug program.Key ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process … more
- Formation Bio (New York, NY)
- …products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team; foster a culture ... biologics manufacturing processes, formulation development , analytical methods, and global regulatory requirements. Proven ability to lead cross-functional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global affiliate health authority ... various areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of… more
- Merck & Co. (Rahway, NJ)
- …scientific & medical affairs plans for their assigned Therapy Areas (TA). They build and lead a team of TA dedicated global and regional directors and associate ... and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders....click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity… more
- Merck & Co. (South San Francisco, CA)
- …assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical ... Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for planning and management of an important… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …achieve analytics and insight delivery speed and efficiency through automation and GenAI application development . To help drive the AI CoE's mission, this role ... a track record of process improvement Industry Knowledge Experience in AI/GenAI application development for healthcare is preferred The base compensation range… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global affiliate health authority ... internal audits and inspections Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of… more
