- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Merck & Co. (Rahway, NJ)
- …Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies ... needed Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio… 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 ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... capabilities and will be responsible for planning, coordinating, and executing timely and high- quality submissions to the FDA.This is a hybrid position based in our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... final contract, including project management, supply analysis, supplier identification, risk mitigation, sourcing execution, high level negotiations, award of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HR operations within the organization. By exercising financial prudence, identifying risk areas, and maintaining transparent reporting, the role supports the ... has a matrix reporting relationship and reports to the Director , People Operations and closely partners with all leaders...-1 for monthly review and quarterly POLT Ops Identify risk areas and contribute to the development of remediation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Associate Director , RBQM - HOCT, ICN will mainly be responsible ... critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , RBQM - HOCT, ICN will mainly be responsible for ... critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to… more
- Capital One (New York, NY)
- Senior Director , Design - Risk and Audit...our digital products through our high standards of craft, quality and security. TEAM DESCRIPTION Our Risk ... that drive our Enterprise Staff Services which power our Risk and Audit domains. Over 40,000 associates in Capital...and the next generation of enterprise platforms. As Sr. Director , Design, you will help shape and deliver on… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director of Specialty Laboratory Vendor Quality will be mainly ... quality perspective and delivering the full range of quality . This role reports directly to the Director...vendor audits, including audit scope to assess the vendors risk , quality systems, capabilities and performance +… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be ... project/products, to Health Authorities and RGO . + Translate risk factors into Clinical Quality Assurance oversight.... + Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit… more
- Bristol Myers Squibb (Summit, NJ)
- …than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to Contract ... reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles + Must be able to… more
