- Merck & Co. (Upper Gwynedd, PA)
- …Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance , Regulatory ... regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Merck & Co. (Rahway, NJ)
- …Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ 4 more}-Preferred ... model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs ,...health authorities.- Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements,… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director, Policy. Other internal relationships include a dotted ... line with Corporate Tax, as well as other Market Access & Public Affairs teams, Medical, Legal, Compliance , Communications and other key stakeholders locally and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(Pricing, Contracting, Operations and Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs , and Legal & Compliance . External relationships include ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... guidance of a senior leader, this position supports value evidence outcomes research...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs , Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance . External ... Works closely with Enterprise Insights, Finance, Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts… more
- Merck & Co. (North Wales, PA)
- …Product Development Teams, Franchise Teams, Regional Product Directors, affiliates, Public Affairs , and Medical Education to ensure value evidence programs are ... strategies and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement… more
- Nuvalent, Inc. (Cambridge, MA)
- …Arizona (AZ), Colorado (CO), Texas (TX), and Utah (UT). The Role: Reporting to the Senior Director, US Field Medical Affairs , the Senior Medical Science ... of deliverables. Success will require the individual to have relevant Medical Affairs and Oncology experience. This role is a field based, non-promotional medical… more
- Wurth Baer Supply Company (Vernon Hills, IL)
- …have expertise in compliance risk management, corporate governance, and regulatory affairs while possessing strong communication, investigative, and conflict ... investigation findings, and remediation efforts . Prepare reports for senior leadership on compliance risks, regulatory...plus. Experience: Minimum 5 years of experience in corporate compliance , business ethics, or regulatory affairs… more
- Mohawk Valley Health Systems (Utica, NY)
- Job Summary The Senior Director of Quality Management Systems and Regulatory Affairs is responsible for establishing and promoting quality outcome standards ... the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and executing large scale… more
- GRIFOLS, SA (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Affairs Specialist I Primary responsibilities for role: Act as Regulatory Affairs representative for specified key products/facilities/equipment. Prepare… more
- Petco (San Diego, CA)
- …legal operations, or commercial negotiations. Strong understanding of contract law, regulatory compliance , and risk management. Proven ability to manage ... good for Petco. Key Responsibilities: Serve as a strategic partner to senior leaders and cross-functional stakeholders by overseeing the negotiation, review, and… more
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular ... impact of decisions across functional areas. As a strategic leader within the Regulatory Affairs organization the incumbent will be instrumental in the evolution… more
