- Merck & Co. (Rahway, NJ)
- …knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they ... lead to ensure high quality products and...a minimum of 10 years of combined experience in medical device and combination product development. Advanced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... in the hemophilia and growth disorders therapeutic areas, new products in the pipeline, and ...in-depth understanding of the competitive landscape, market research, historical products , and payer landscape Lead market development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... and an in-depth understanding of the competitive landscape, market research, historical products , and payer landscape. Lead market development and unbranded… more
- Merck & Co. (North Wales, PA)
- …review process for our promotional content.- Seize this opportunity to drive innovation and lead the way by becoming the IT product owner for these ... distribution, and compliance of promotional material.We are looking for an experienced product owner who will drive content quality capabilities that improve our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and the Global organization to drive strategic development of medical products providing patients with integrated product solutions, based on an ... education and collecting data to support efficacy and new product development, CMR is involved. The...opinion leaders, consultants, and key customer groups. Essential Functions Lead US input to overall product development… more
- Merck & Co. (Rahway, NJ)
- …efficacy data required for regulatory approval of potential new drugs and new indications for existing products . We ensure we conduct high quality clinical ... rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as needed and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025...centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategic Application product roadmaps to meet business goals and objectives. Lead the definition of solutions based on business needs, cost, and required ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage vendor relationships, Product Vendors and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...promoting innovation, and seeking ways to optimize operations through new technologies or practices Stakeholder Management: Engaging with internal… more
- Genmab (Plainsboro, NJ)
- …committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of ... will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market...focus of the role is the active support of product -oriented development (POD) teams in the security of processes… more
- Genmab (Plainsboro, NJ)
- … Medical Affairs Solid Tumors Strategy will report to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead . S/he will provide medical ... portfolio. The individual will lead the development and execution of the US Medical Affairs strategy that is aligned with the company's goals and meets the needs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guides, EU SmPC, EU PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling ... an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs)… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. The ... Job DescriptionThe Executive Director, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and execution… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …as directed by the Quality Manager. In addition, the Quality Engineer will lead continuous improvement efforts following a structured methodology such as six sigma. ... Validation on Time.Job ResponsibilitiesChange Management - evaluate the impact to product , processes, and equipment changes on critical attributes and quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...America Operations (NAO) CMR organization on all aspects of new and existing CMR employee on-boarding, cultural engagement, technical/role-specific… more
- Genmab (Plainsboro, NJ)
- …Digital Strategy - Medical /Access/PSS & Paid Media will serve as the lead digital strategist across our Medical , Market Access, Patient Services and ... committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of… more
