- Merck (Upper Gwynedd, PA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Merck (Upper Gwynedd, PA)
- …, Business Development Execution, The primary function includes coordinating various GRACS ( Global Regulatory Affairs and Clinical Safety) functional areas, ... to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but… more
- Merck (North Wales, PA)
- **Job Description** The Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and ... work cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area...in a highly matrixed environment is critical. The Executive Director provides strategic and tactical direction to the field… more
- Merck (North Wales, PA)
- …best practices in those areas + US/ Global experience in clinical research, regulatory affairs , scientific and medical affairs , and pharmaceutical policy ... Center of Excellence + Therapeutic Area Leadership + State Government Affairs & Policy + Global Policy and Corporate Communications Teams + US Federal Policy &… more
- Merck (West Point, PA)
- … Global Clinical Supply, Global Clinical Trial Operations, Translational Medicine, Global Regulatory Affairs & Clinical Safety and Quality functions ... **Job Description** The Executive Director of Global Clinical Supplies Quality...of Quality professionals assuring the reliable availability, quality and regulatory compliance of clinical supplies in support of the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …other functions and strategic partners such as R&D, Manufacturing, Medical Safety, and Regulatory Affairs to establish, drive, and achieve excellence in product ... and oversee the following processes in support of the Global Design Assurance team: + Oversight over the ...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Merck (Upper Gwynedd, PA)
- …collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in ... **Job Description** In this Principal Scientist/ Director position within Translational Oncology, this team member...IDEs, IVDR PSAs, PMAs. + Participate in meetings with global regulatory agencies to provide CDx expertise.… more
- Bausch Health (Easton, PA)
- …including Project Management, CMC, Analytical Sciences, Nonclinical, Clinical Operations, Clinical/Medical Affairs , Biostatistics, and Regulatory Affairs . + ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...and values drive our collective progress and impact. The Director of Clinical Pharmacology will provide expertise and support… more
- Teva Pharmaceuticals (North Wales, PA)
- …units by including other GxP supporting functions such as Supply Chain, Regulatory Affairs , Medical, Pharmacovigilance + Represents US Commercial Quality in ... Director Commercial Quality US Date: Mar 13, 2025...associated resources, compliance activities including complaints and recall management, regulatory event reporting, drug shortage reporting, Health Authority, US… more
- Merck (Upper Gwynedd, PA)
- **Job Description** **Title: Associate Principal Scientist/Associate Director , Outcomes Research** **Role Summary** + Under the guidance of a senior leader, an ... Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and...Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Merck (North Wales, PA)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... areas. You will report directly to the Medical Safety Director as a member of the global ...806, 820), various standards (GCP, ISO 13485, ISO 14971), regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs,… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, The Senior Director … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... Material, Training and Document Control and may be called upon to support Global Ship Hold activities. They support the Director , Site Quality Systems… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + Lead or ... Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical Quality Assurance and provides support to ensure the… more