- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director … more
- Merck & Co. (North Wales, PA)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and dedicated colleagues while developing and expanding your career.-- Director (Principal Scientist) has primary responsibility for the planning… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May… more
- 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 (North Wales, PA)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… 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 ... **Job Description** Reports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… 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 ... Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products,...participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Global Commercial Insights and Analytics, Autoantibody (Horsham, PA) - 2406206641W **Description** Johnson & Johnson is seeking a Associate ... Director , Global Commercial Insights and Analytics, Autoantibody...collaborating and communicating cross-functionally with competitive intelligence, finance, medical affairs , regulatory and other key functions +… more
- Pfizer (Collegeville, PA)
- …medicines and vaccines. **What You Will Achieve** The Senior Manager, Global Regulatory Strategy for Oncology provides support to Director and above ... regulatory professionals by executing against the global regulatory plan for one or more...Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs… more
- CSL Behring (King Of Prussia, PA)
- The Sr. Director , Head of Global Medical Information will oversee the global core functions of Medical Information across all therapeutic areas/products at ... stakeholders across the organization such as Clinical R&D, Pharmacovigilance, Quality, Marketing, Global Market Access/HCS, Heads of Medical Affairs in the US… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …Lead will provide clinical development support and guidance into global regulatory interactions, will assist the Medical Affairs team, as necessary, and ... Senior Medical Director - Neurology **Date:** Oct 13, 2024 **Location:**...internally as clinical development expert for global regulatory interactions; collaborate with Regulatory Affairs… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …and CDx program SME for other functions requiring input from CDx. Support Regulatory Affairs in providing content and providing review of documents supporting ... for CDx programs. Participate PMA preparation in partnership with Regulatory Affairs and Dx partner. Advise as...GMP requirements; working knowledge of requirements for US and global regulatory submissions related to IVDs for… more
- CSL Behring (King Of Prussia, PA)
- …also partner with teams from Global Commercial Development, Clinical Research and Regulatory Affairs to ensure North America is represented on all future ... **CSL Behring is seeking a Sr. Director , New Product Planning & Evidence Generation (US...multiple teams and people including marketing leadership, US Medical affairs , US Health Care Systems teams, global … more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more
- Organon & Co. (Plymouth Meeting, PA)
- …and development operations across the functions (Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs ) and the drug ... of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least… more
- J&J Family of Companies (Horsham, PA)
- …with business partners, such as Real-World Research, Real-World Analytics, Medical Affairs , Marketing, Strategic Customer Group, Global Commercial Strategy ... Associate Director , Real World Value and Evidence - Hematology...propositions in assigned areas of responsibility. Ensures compliance with regulatory , legal, and commercial regulations (for example Contract Pricing… 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
- Pfizer (Collegeville, PA)
- …Business Development, Pfizer Ventures, PRD, ORD, PGS, PC1, Quality Assurance and Regulatory Affairs functions to accomplish business objectives. + Must have ... to advance innovative therapies. Pfizer Ignite offers unique differentiated capabilities with global scale and capacity, industry leading speed and quality, and a… more
- CSL Behring (King Of Prussia, PA)
- …content supply chain fulfilling the needs of Marketing, Market Access, and Medical Affairs at the time of launch and throughout brand life-cycle, committed to ... goals in content management, including the evolution from a Global COE to global shared services +...services + Working in close collaboration with Marketing, Medical Affairs and Market Access stakeholders to ensure content development… more
