- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …administrative deliverables.Represents OEDC internally and externally as needed by OEDC leadership team . This includes liaising with senior executives in global ... direct accountability for administrative deliverables, will interact regularly with senior leadership and will play a role to integrate...of committee communications and responses. - The OEDC Program Lead leads an agile team in a… more
- Merck & Co. (Rahway, NJ)
- …Utilities and Validation. We are seeking a Growth and Improvement minded Senior Scientist, Engineering that can help drive our Strategic Operating Priorities.Invent ... responsibility, mentoring, and leadership of internal and external work. This Senior Scientist, Engineering position leverages significant depth and breadth of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... living. Are you ready to make a difference? The Position Serve as lead for CRM (customer relationship management) system supporting NNI Medical Affairs. Assumes… more
- Genmab (Plainsboro, NJ)
- … Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team .As Senior Clinical Drug Supply Manager you will play a pivotal role ... development of mitigation plans for operational challenges.Mentor and coach team members, fostering a collaborative and high-performing environment. Lead … more
- Merck & Co. (Rahway, NJ)
- …bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our Company Research Laboratories is committed to ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Director, HEOR Modeling. The role works alongside with other colleagues in the Modeling team and HEOR teams to lead and execute HEOR modeling projects. Essential ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...product strategies, proposed modeling methods, budget, timelines, and deliverables Lead a matrix team and selected vendors… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives Lead a team of Role-Specific Training Support Partners to ensure ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leaders, advisory boards, industry councils and the broader medical community. Essential Functions Lead the clinical informatics team in the (CDSE) department of ... leadership team and oversees NNI due diligence and other senior level oversight associated with the role Internal/external relationships: Foster development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... you ready to realize your potential? The Position The Senior Manager Market Access Channel Strategy is part of...Manager Market Access Channel Strategy is part of a team responsible for developing channel strategies that will ensure… more
- Merck & Co. (Rahway, NJ)
- …development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position ... is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success of...IH sampling activities for new or existing equipment. Support data rich experimentation at pilot scale via process analytical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data… more
- Genmab (Plainsboro, NJ)
- …for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab ... Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to ... development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research...our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure alignment of HCP brand objectives, KOL engagements, and strategies. The HCP - Strategy Lead (MASH) has a team of HCP and KOL strategists reporting to ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and ... risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/ Senior Director - Safety Surveillance, ... teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...program operations and technology systems. This position will also lead the development of operational business plans to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for developing and continually growing strong relationships with DS internal senior stakeholders to assess, develop, implement and drive execution of Strategic ... program for DSI, for DS products and alliances. Cultivates a high performing team by coaching and developing as they support all strategic sourcing responsibilities.… more
