- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …resource allocation. Relationships Reports into Clinical Development & Operations (CDO) Director / Associate Director . Establish and manage relationships with ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....overall business objectives. Align on project strategy with Portfolio Director and TA heads Resource Management: Managing resources such… more
- Merck & Co. (Rahway, NJ)
- …and 10 years overall within biopharmaceuticals. Planning and facilitating high risk and highly complex Quality -related process reviews and/or investigations ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Merck & Co. (Rahway, NJ)
- …to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, accountable ... 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)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… 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
- 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
- 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
- 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)
- …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)
- …, 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
- 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
- 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 (Princeton, 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
- Dow Jones (Princeton, NJ)
- Dow Jones is looking for an Associate Director , Due Diligence Quality to join our Due Diligence team responsible for the creation of high- quality reports ... a combination of publicly-available sources and proprietary databases. As Associate Director , Due Diligence Quality ,...and deadlines are met. You will report to the Director , Risk & Compliance Services. You Will… more
- Humana (Trenton, NJ)
- …part of our caring community and help us put health first** The Associate Director , Compliance ensures compliance with governmental requirements. The ... Associate Director , Compliance requires a solid understanding of how organization...policies and strategies that help to minimize overall enterprise risk . The individual will be responsible for researching compliance… more
- Merck (Trenton, NJ)
- **Job Description** An opportunity has arisen for an **External Manufacturing Operations Associate Director .** Our Manufacturing & Supply Division is dedicated ... on time, every time. Based out of the United States, the **ExM** **Operations Associate Director ** is accountable for meeting customer demand at the Contract… more
