- Genmab (Plainsboro, NJ)
- …with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. ... Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required...relevant. Support global regulatory lead and labeling strategy lead in development of the Company… more
- Genmab (Plainsboro, NJ)
- …organization.In this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the ... time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global ... the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the… more
- Genmab (Plainsboro, NJ)
- …current US and global regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... of a single or multiple clinical trials from strategy outline through to...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and oversees its tactical execution Oversees and leads pricing and contracting strategy , playbook, and guideline development for all new product launches ... Global Market Access to develop pricing scenarios and strategy for all pipeline products starting in Phase II...across the franchise Leads the optimization of the contracting strategy and roadmap development for the Commercial,… more
- Genmab (Plainsboro, NJ)
- …entire spectrum of drug development at Genmab, from Discovery to Late Clinical Development and beyond.The Head of Clinical Pharmacology & Quantitative ... CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology strategies for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... NJ. We support programs from early research through late-stage clinical development . We are building for the... Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to… more
- Genmab (Plainsboro, NJ)
- …the needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development , Regulatory, and other ... development and execution of the US Medical Affairs strategy that is aligned with the company's goals and...expert in both internal and external venues including the US/ Global cross-functional teams, clinical development … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …specified therapy area preferred HCP marketing experience leading brand/therapy area strategy development and driving impactful customer experiences is required ... management and strategic collaboration HCP KOL marketing experience leading brand strategy development and driving impactful customer experiences is required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical informatics tools development to support the CMR organization. This individual ... will serve as a subject matter expect on clinical and medical informatics software and system development...strategy , portfolio, and product strategies as well as Global strategies. Drive understanding and appropriate use of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …qualitative or quantitative method review) Facilitates integration of the US PED strategy into clinical development programs, post-authorization and ... in generating patient insights about disease and treatment to support clinical development , post-authorization, and commercial research activities across the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to develop innovative, insights-driven HCP omnichannel branded and TA unbranded market development strategy to support brand/therapy area development and ... guide HCP experiences HCP KOL marketing experience leading brand/therapy area strategy development and driving impactful customer experiences preferred… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trainers and knowledge management staff. Closely partners with line leaders, Global Development key stakeholders, HR organization in understanding, designing ... and adult learning KOLs as required. May also provide input or implement global Development and R&eD training initiatives. Essential Functions Responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish and manage relationships with external partners relevant to the strategy , design & implementation of clinical trials improvement/innovation projects ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...relationships positively with multiple internal stakeholders relevant to the strategy , design & implementation of clinical trials… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, Development , innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive leaders, and ... for the TA. This role also contributes to the global TA strategy by working closely with...maximize customer centricity across the Rare Bleeding TA Commercialization Strategy Support development of the therapy area/brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, Development , innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive leaders, and ... About the Department The Strategy & Rare Disease (STARS) organization drives the...portfolio. The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...etc.) and that is in alignment with the regulatory strategy . This individual works cross-functionally with internal and external… more
- Merck & Co. (Rahway, NJ)
- …consultation or operations support needsEnsure an exquisite partnership with Global Clinical Trial Operations, Regulatory and other Development Sciences and ... Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division , is accountable for managing the 'end-to-end'… more
