- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior ... Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide medical affairs leadership for...commercial, and market access teams to incorporate insights into product strategies and to support product launches… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings ... for assigned product . Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving. Serve as… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and delivery of the clinical development plan in alignment with the product development strategy .Manages the team meetings including developing the agendas ... Global Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 marching to ... of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quarterly Reports) in paper and electronic format.Participate in global product team meetings (development and marketed products); provide regulatory support ... and guidance and manage day-to-day regulatory activities.Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct reports.Review and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy ... in the Project lead.ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 marching to ... Are you ready to make a difference? The Position Drive portfolio strategy and study management activities and manage cross-functional study team, external service… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the effective strategy , design, execution, and interpretation of Oncology clinical trials....consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information ... role at Genmab, dedicated to translating and executing the information security strategy and objectives in close collaboration with business and functional teams. As… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 marching to ... for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC Lead of an early-stage project. He/she has responsibility for the overall strategy and status of the project with respect to budget, timeline, achievement of ... meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Strategy & Rare Disease (STARS) organization drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations ... is to facilitate the development and to coordinate the execution of the long-term strategy , defining a sustainable business model in US beyond a 5-year time horizon.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborates closely with data manager to ensure high quality data.Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Tris Pharma (Monmouth Junction, NJ)
- …concept, implementation, executionExcellent working knowledge and experience with marketing strategy and product positioningExperience with digital campaign ... from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director , Head… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that ... ability to travel over 50 %.Head, Medical Science Liaisons (MSLs) / Director , Medical Training, Pain therapeutic space is responsible for field leadership of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible for leading ... projects, and process automation initiatives. BPM Knowledge Development and Product Enhancement:- Enhance stakeholders' BPM knowledge through training, coaching, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The ... the highest possible business value, while subscribing to the enterprise IT strategy . Additionally, this role collaborates with technical and business leaders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborates closely with data manager to ensure high quality data.- Drug Development Strategy : Provides input to multiple aspects of the development plan to ensure ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with customer partnership activities in NNI and ensure alignment with NNI enterprise strategy , portfolio, and product strategies as well as Global strategies. ... 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 marching to… more
