- Merck & Co. (Rahway, NJ)
- …will:Lead and manage cross-functional and cross-site launch readiness teams to prepare internal Global Biologics Operation (GBO) sites for successful PPQs and ... commercializing and supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head… more
- Merck & Co. (North Wales, PA)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... leadership in driving toward study goals.Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... RoleGenmab is currently seeking a Hematology Medical Science Liaison (MSL)/ Senior MSL (Sr. MSL) to be a part of...an exciting opportunity of a passionate, high profile, high-impact Global Medical Affairs team, and work in a dynamic… more
- Merck & Co. (Rahway, NJ)
- …authorization, execute of post marketing commitments and meet compliance obligations.Qualifications and Skills:Required: Global Regulatory experience required ... Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance , Global Health, Global Program Development, High… more
- Repligen (Waltham, MA)
- …and supporting strong analytical approach with teams across the organization. Internal Controls & Compliance :Design, implement, and maintain effective ... OverviewOur fast-growing and acquisitive global public company is looking for a strong,...internal controls over financial reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with… more
- Repligen (Rancho Dominguez, CA)
- OverviewWe are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer ... technical leadership at the site level while collaborating closely with our global engineering network to deliver strategic initiatives.The ideal candidate has a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent, ... the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory), Finance, and Novo… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across internal and external stakeholders and partners Maintain robust compliance , quality and privacy standards in handling customer information and programs ... you in? Are you ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology,… more
- Merck & Co. (Rahway, NJ)
- …of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities :Develops, coordinates, and provides biostatistical support for ... staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.Evaluates appropriateness… more
- Formation Bio (New York, NY)
- …large molecule programs from early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a ... to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC)… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all ... This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision… more
- Merck & Co. (South San Francisco, CA)
- …our R&D partners.Position Description/Summary:Under the broad direction of the Senior Director or Director, Strategic Alliances, the Associate Director, Strategic ... executed by Corporate Business Development (Corp BD).- Responsibility includes engaging internal and partner leaders at all levels to maximally leverage assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... third-party vendors, system providers, and validation partners to ensure compliance , contract fulfillment, and service excellence.Oversee global project… more
- Merck & Co. (Upper Gwynedd, PA)
- … Global Team Collaboration, ICT Strategy, Information Technology Planning, Internal Communications, IT Business Solutions, IT Operation, IT Project Lifecycle, ... driving sustained adoption of new capabilities and tools that will advance how the global IT organization plans and delivers work. This role is responsible for the… more
- Merck & Co. (North Wales, PA)
- …of medical drugs and vaccines for the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is ... and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with ... key internal and external stakeholders. Collaborates with counterparts across the...Advocate for US marketing initiatives within the context of global marketing and closely coordinate campaign development, competitive defence,… more
- Merck & Co. (North Wales, PA)
- …development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
