- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization and contact volume grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality/ Safety Associate Director . Interacts ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The AD will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange ... process improvements.Provide oversight, Manage Implementation and documentation of PV Safety systems Change Request supporting documents and evidenceReview of Change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance of NNI data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... to Senior Leaders in the Line of Business. In this role, the Director will demonstrate exceptional ability to proactively partner with and appropriately influence… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... Start-Up activities for PV Safety Operations. This position oversees the creation of SAE...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Merck & Co. (Rahway, NJ)
- …breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical ... Research Group. Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical ... Safety global business processes. This includes defining and optimizing...for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director ... of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development through… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Discovery Process Chemistry, RahwayDescriptionThe Director , Discovery Process Chemistry is responsible for managing a portfolio of projects ... including management of API supply during this period.-Nature and Scope of PositionThe Director reports to the Executive Director of Discovery Process Chemistry,… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, ... Focus and Purpose -The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning and directing clinical research activities… more
- Merck & Co. (Rahway, NJ)
- …Crystallization Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices ... internal resources and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and ... particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse ... as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …(BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP ... compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area… more
