- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including vendor outsourcing agreements, PV Agreements ... reporting, periodic reporting and risk management. Develops and implements strategic initiatives for global process harmonization and continuous improvement across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as developing activity plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with ... and an integral member of the decision making in the Project lead .ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and the technology providers to deliver GxP application solutions. Responsible for Strategic Application product roadmaps to meet business goals and objectives. ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… 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 ... and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on assets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project management, drug development expertise to Global Project Teams including strategic development and execution of an integrated product development ... with the Global Team leader as the Project Management lead on drug development projects. This position can be...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… 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 ... efforts. This role involves aligning process improvement initiatives with strategic business goals, managing the global process landscape, and fostering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with ... often works with ambiguity and complex problems, focusing on strategic and operational decisions.ResponsibilitiesActs as point of contact for cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Product Team (GPT) as an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the ... Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of...to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Product Team (GPT) as an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The purpose of this job is to lead certain pipeline support activities and assist in the identification, coordination assessment, ... will also support more complex projects, including those to acquire new product opportunities or technologies to augment our pipeline. This person is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and therapeutic areas (TA), under the guidance of the Associate Director , GOMA Scientific Engagement.Contribute to the management and execution of activities ... to provide insights and support to the cross-functional GOMA team including TA lead , medical information & education, patient advocacy, and publications, as well as… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... this role, you will work in close collaboration with the Global Regulatory Lead (s) on a compound in late-stage development to implement the US regulatory strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data (PED) evidence to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...you ready to make a difference? The Position The Director , Patient Centered Outcomes Research, is responsible for the… more
- Genmab (Plainsboro, NJ)
- …team, and labeling working group meetings, as required for the assigned projects Lead the strategic development of briefing materials and prepare teams for ... portfolio of development pipeline candidate drugs. This individual will provide strategic input and ensure operational execution of global (and US) submission… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.Job Description - Director , Digital Assets, Information SecurityPosition Summary: The Director Information ... focus of the role is the active support of product -oriented development (POD) teams in the security of processes...and will be onsite 60% of the timeReporting StructureThe Director Information Security will report directly to the VP… more
- Genmab (Plainsboro, NJ)
- … 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 ... 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… more
- Genmab (Plainsboro, NJ)
- …and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part of our IT & ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… 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 ... ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department...will serve as an integral member of the CMR Strategic Operations (SO) Leadership Team and will be responsible… more
- Genmab (Plainsboro, NJ)
- …fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... 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
- 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 ... advisory boards, industry councils and the broader medical community. Essential Functions Lead the clinical informatics team in the (CDSE) department of NNI focused… more
