- 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 (Philadelphia, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... release from our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within internal committees to provide … more
- Chemours (Wilmington, DE)
- …improvement at a time. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing **Government Affairs ** team! This position ... **Washington, DC** office. The successful candidate will join Chemours' Global Government Affairs Group with a primary...Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States… 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 ... high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and… 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
- Organon & Co. (Plymouth Meeting, PA)
- …regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation ... **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and...to assess acceptability and identify potential risks. + Execute global regulatory strategies by leading the development,… more
- Takeda Pharmaceuticals (Exton, PA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Merck (Upper Gwynedd, PA)
- **Job Description** We are currently recruiting for a ** Director Global Oncology Marketing** for Lung cancer for our Company's oncology business. The Global ... in Rahway, NJ and will report to the Executive Director , Global Marketing for NSCLC. The position...complex set of stakeholders, including research and development, medical affairs , regulatory affairs , market analytics,… more
- ThermoFisher Scientific (Wilmington, DE)
- …highly motivated and experienced individual to join our team as Global Medical Director , Allergy on the Medical and Scientific Affairs (MSA) team. In this ... quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at...different departments, such as marketing, sales, manufacturing, quality and regulatory affairs . You will also collaborate with… more
- Black & Veatch (Wilmington, DE)
- ** Global Benefits Director ** Date: Oct 22, 2024 Location: Overland Park, KS, US US Company: Black & Veatch Family of Companies **Together, we own our company, ... questions and put your diverse talents and perspectives to use. **The Opportunity** The ** Global Benefits Director ** will have the opportunity to: + Lead the… more
- Merck (Upper Gwynedd, PA)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Business Development ... competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized… 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:** Nov 11, 2024 **Location:**...internally as clinical development expert for global regulatory interactions; collaborate with Regulatory Affairs… more
- Takeda Pharmaceuticals (Exton, PA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... the US Medical team, you will report to the Director , Ad/Promo Regulatory Review. You will be... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Clinical Statistics Date: Oct 18, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 57783 **Who we ... and new people to make a difference with. **The opportunity** The Director , Clinical Statistics is a skilled statistician with significant experience in drug… 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)
- …in supporting ongoing clinical research and interface extensively with Clinical Development, Regulatory teams, and Medical Affairs , among other internal teams, ... to Associate Vice President of Clinical Data Sciences (AVP CDS), the Executive Director of Biostatistics will play a key role in leading and contributing to… 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
- CSL Behring (King Of Prussia, PA)
- …or Waltham MA. This is a hybrid position. You will report to the Director , Medical Affairs Biostatistics. **Responsibilities:** You will be a subject matter ... CSL Behring is a global biotechnology leader, guided by a promise to...often rare conditions. Could you be our next Associate Director , Observational Research Excellence ? The job is located… more
- Teva Pharmaceuticals (West Chester, PA)
- …+ Guide decision-making to minimize IP risk + Collaborate with Legal and Regulatory Affairs to ensure effective Hatch-Waxman strategy (exclusivity, Orange Book ... Senior Director , Patent Attorney - Small Molecule Innovative IP...address legal issues arising from development plans, commercialization, and regulatory strategies + Work with IP litigation colleagues to… more