- Genmab (Plainsboro, NJ)
- …Clinical Scientist area and looking for a Sr Clinical Research Scientist (CRS) to join the team .You will as a Senior CRS be part of the Medical department and ... eCRFs completion guidelines, and provide scientific support for other key data management deliverables (eg database lock activities). Lead the development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy ... and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement...Policies & Training, Monitoring & Auditing, Investigations, Technology & Data Analytics. This leader plays a critical part in… 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
- 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)
- …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
- 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
- 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 ... a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting planning 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 ... and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... with the yearly review of current pricing strategies Develops world-class data gathering process to capture competitive pricing and discounting Supports business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …up-to-date on changes and related needs for patient support Develops recommendations and lead team to implements program changes to ensure ongoing compliance, ... and Market Research. The position has high exposure to senior management and requires a highly motivated individual who...program offerings Support the annual brand planning process with data driven insights Lead and execute ongoing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, we're committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. Operating at the highest ethical & privacy ... and ensuring adherence to corporate and legal regulations, this team is constantly called upon to design and implement...organization's top risk areas. The role serves as the lead Ethics & Compliance Business Partner for assigned departments… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE team . This role will interact ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...(EGP). Externally, the Associate Director RP will be the lead for research within a specific therapeutic area (eg,… more
- 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
- Genmab (Plainsboro, NJ)
- …to the Senior Director, US Medical Affairs Solid Tumors Strategy Lead . S/he will provide medical affairs leadership for assigned asset(s)/indications and support ... for the overall oncology solid tumor portfolio. The individual will lead the development and execution of the US Medical Affairs strategy that is aligned with the… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse backgrounds and bringing subject matter expertise related… 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
