- J&J Family of Companies (Spring House, PA)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory ... and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional...senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle… 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... agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in… more
- Merck (North Wales, PA)
- **Job Description** We are seeking a Senior Director ( Sr . Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented ... drive our strategic priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… more
- Merck (North Wales, PA)
- **Job Description** Reports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- CSL Behring (King Of Prussia, PA)
- …within Medical Affairs . Based on knowledge of worldwide legal and regulatory requirements and internal standards, you will oversee the revision of existing ... **The Opportunity** Reporting to the Executive Director , Strategic Projects, you will identify, oversee and support the implementation of required changes and… more
- Takeda Pharmaceuticals (Exton, PA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Teva Pharmaceuticals (West Chester, PA)
- …key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director will provide input ... and other global regulatory filings. **How you'll spend your day** The Senior Director will foster relationships with opinion leaders in assigned areas. +… more
- Takeda Pharmaceuticals (Exton, PA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** About the role: Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Merck (North Wales, PA)
- …under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations ... Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS), and QA… 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 CSL ... Clinical R&D, Pharmacovigilance, Quality, Marketing, Global Market Access/HCS, Heads of Medical Affairs in the US and International, TA Heads and global medical… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Patent Attorney - Small...to minimize IP risk + Collaborate with Legal and Regulatory Affairs to ensure effective Hatch-Waxman strategy ... a difference with. **The opportunity** We are seeking a dynamic and experienced ** Senior Director , Patent Attorney - Small Molecule** to develop and implement… more
- Merck (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career. The Senior Director ( Sr . Principal Scientist) has primary responsibility ... placement, monitoring, analysis, regulatory reporting, and publication. Specifically, The Senior Director May Be Responsible For + Evaluating pre-clinical… more
- Merck (North Wales, PA)
- …and resources to address the opportunities. + Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs ... **Job Description** **Job Description:** The Associate Director , Marketing, HPV Scientific Strategy plays a critical...One Company approach. + Collaborating with Program Leads, Medical Affairs and Global Expert Management & Strategy to plan… more
- Teva Pharmaceuticals (West Chester, PA)
- …have a significant impact on drug development programs and have visibility with senior level management. A Director , Clinical Statistics may be an individual ... Director , Clinical Statistics Date: Oct 18, 2024 Location:...significant experience in drug development and clinical research, including regulatory interactions both inside and outside of the US.… more
- J&J Family of Companies (Spring House, PA)
- …Development, Therapeutic Area Teams, Health Policy and Advocacy, Communications, Scientific Affairs , R&D, Senior Leadership) + Monitor the stakeholder ... Director , Patient Advocacy, R&D - 2406216492W **Description** Johnson...bioethics, legal, policy, and compliance. Externally, with patient organizations, regulatory bodies and other external stakeholders. The Patient Advocacy… more
- Merck (North Wales, PA)
- **Job Description** Under the guidance of a senior leader, the Principal Scientist, Outcomes Research-Women's Cancer has primary responsibility for developing value ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… 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 ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be… more
- CSL Behring (King Of Prussia, PA)
- …manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs , Project Management, Operations and Commercial Operations ... 3 sentences). The purpose of the position of Executive Director R&D Quality is to lead a dedicated team...is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams and across… more