- Atlas Data Systems (Wilmington, DE)
- …to drive decision-making and optimize launch plans. Collaboration with marketing, sales, regulatory affairs , medical affairs , and other departments is ... building centers of excellence, creating scalable playbooks, and driving regulatory approvals. Accountable for a successful design, development, and implementation… more
- Atlas Data Systems (Wilmington, DE)
- …and optimize business processes using data insights. Collaborate with marketing, sales, regulatory affairs , medical affairs , and other departments to ... and processes to improve efficiency and effectiveness in project operations . Ensure all project activities comply with regulatory...Who you will be working for: Atlas is a global strategic consulting firm, focused on the life sciences… more
- 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)
- **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)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… 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
- Merck (North Wales, PA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical...with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead, is responsible for development… more
- J&J Family of Companies (Horsham, PA)
- Principal Scientist, CMC Regulatory Affairs - 2406205078W **Description** Johnson & Johnson is recruiting for a **Principal Scientist, CMC Regulatory ... potential. At Johnson & Johnson, we all belong. The Principal Scientist, CMC Regulatory Affairs provides support for the registration activities for a diverse… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist (Associate Director) is… 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
- Sumitomo Pharma (Trenton, NJ)
- …Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and ... with the US Field Medical team, Medical Communications & Operations , Japan medical affairs colleagues, RWE (Real...global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada… more
- Bausch + Lomb (Trenton, NJ)
- …**Contacts (Internal And** **External)** + **Internal:** US Medical Affairs , Regulatory Affairs , Clinical Operations , Research & Development/Life Cycle ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...eye health in the future. **Position** **Summary** The Medical Affairs Director provides support to the Medical Affairs… more
- West Pharmaceutical Services (Exton, PA)
- …Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global portfolio of medical devices, ... quality assurance, clinical affairs , labeling, to align on deliverables for global submissions, establish key regulatory positions, and to ensure product… 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)
- …+ 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
- Merck (North Wales, PA)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Health Economics ... commercialization, including product development team, target product profile development, global regulatory filing strategy, launch readiness reviews, organized… more
- Merck (North Wales, PA)
- …Scientific Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standards + Commercial lead in driving engaging ... Vaccines Franchise brands at Congresses; identifying strategic congresses for Global support, including key regional congresses, aligning team activities, and… more
- Pfizer (Collegeville, PA)
- …In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations , the CS is responsible for execution and project ... the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations , Medical/Scientific Affairs , Regional, Pfizer laboratory assay group, and… more
- Pfizer (Collegeville, PA)
- …Management, CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, Market ... of all specialty care projects executed by RWE scientists and the Clinical Affairs & Operations teams, restructuring priorities as needed and participating in… more
