- Olympus Corporation of the Americas (Center Valley, PA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Regulatory Affairs Operations Manager, is responsible for ... objectives. The Operations Manager will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth and efficient delivery… more
- Merck (North Wales, PA)
- …the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations , Process & Systems ... across GRACS. Final External Policy is the official approved version of regulatory requirements or expectations that have undergone a thorough review, consultation,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... mid-size oncology company in the role of Associate Director, Regulatory Affairs Operations where you...community we serve. Position Summary: Under the leadership of Regulatory Affairs the incumbent manages global… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Merck (North Wales, PA)
- …The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business ... various SMEs, including leading cross-functional teams, to drive process improvements, streamline operations , and achieve business objectives on a global scale.… more
- Merck (North Wales, PA)
- …innovative products and services that save and improve lives around the world. The Global Regulatory Affairs and Clinical Safety (GRACS) Quality and ... Compliance (Q&C) team builds trust and confidence with global health authorities by instituting solid & robust processes...& robust processes and systems that adhere to a regulatory quality & compliance framework. The GRACS Quality and… more
- CSL Behring (King Of Prussia, PA)
- …manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs , Project Management, Operations and Commercial ... is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams and across...Pharmacovigilance and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and… more
- Novo Nordisk (Plainsboro, NJ)
- …key internal relationships include global and US stakeholders in other areas of Regulatory Affairs , as well as those who are part of the promotional review ... you ready to make a difference? The Position The Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is...pharmaceutical industry. Therapeutic Area + Assist in preparation of regulatory documents. + Work with global stakeholders… more
- Bausch + Lomb (Trenton, NJ)
- …the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for ... interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain...documents in accordance with project timeline. + Coordinate with Regulatory Operations to ensure timely and accurate… more
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck (North Wales, PA)
- …collaboration with the CSRM physician. + Manage and prepare strategies for regulatory documents and responses to safety inquiries from healthcare professionals, ... regulatory agencies, subsidiary staff and other internal customers in...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Integra LifeSciences (Princeton, NJ)
- …with colleagues in the Marketing, Business Development, R&D/Process Technologies Clinical Operations , Strategy, Regulatory Affairs , Market Access, and ... team. This role works closely with key stakeholders (R&D/Process Technologies, Clinical Operations , Regulatory , Commercial, and other functions) to support the… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... with other GI team members in the US and Global Medical Affairs Organization, as well as...matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight. *… more
- Novo Nordisk (Plainsboro, NJ)
- …Development and Outcomes Research Marketing and Market development, as well as Global Medical Affairs . Essential Functions + Lead projects, representing Medical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Affairs interests on cross-functional teams including, Field Medical Affairs , Medical Operations , Clinical Trial Management, HEOR,… more
- Merck (North Wales, PA)
- **Job Description** **2025 US Medical Affairs Health Systems Oncology Internship** The Future Talent Program features internships that last up to 12 weeks and will ... Development Division is currently recruiting for a summer intern for the US Medical Affairs Health Systems Oncology (HSO) team. The intern in this position will gain… more
- Merck (North Wales, PA)
- …policy management, including data analysis, process development, and partnership establishment within Global Regulatory Affairs . This may involve leading or ... Health, The Policy Execution team drives the assessment, evaluation, and implementation of global regulatory policy across all Operations , Process, and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Serves as a principal assistant to the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs . Responsible for management of the delivery ... operations and functional areas for Medical & Scientific Affairs (MSA) and Quality Assurance & Regulatory ...by the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs , including… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations , Drug Discovery ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Merck (North Wales, PA)
- …see if we are the right company for your long-term goals **Team Overview:** The Global Regulatory Affairs and Clinical Safety (GRACS) Regulatory Digital ... facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... + Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory ...Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead… more