- Merck & Co. (North Wales, PA)
- …promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of the product ... Job DescriptionReports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- Merck & Co. (North Wales, PA)
- …mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead ... Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under...and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Merck (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch + Understanding of the ... **Job Description** Reports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- J&J Family of Companies (Horsham, PA)
- …program leadership and medical oversight. * Contribute to US GI Medical Affairs strategy , working cross-functionally with partners within the GI Integrated ... Medical Director , Gastroenterology Therapeutic Area - Medical Affairs...Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs… more
- Inovio Pharmaceuticals (Plymouth Meeting, PA)
- …and cancers. For more information, visit www.inovio.com . Job summary The National Director , Field Medical Affairs (FMA) will be responsible for providing ... (MSL) and Clinical Device Liaison (CDL) teams. The National Director , Field Medical Affairs (FMA) will report...Affairs plans and objectives that align with Medical Affairs and INOVIO strategy for all marketed… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and...through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located in ... Director , Global Regulatory Leader (GRL) (1...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on the… more
- Merck (North Wales, PA)
- …mitigation measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead ... **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)**...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- Merck (Philadelphia, PA)
- **Job Description** **Position Description:** **Associate Director , Policy Strategy and Capabilities** The Associate Director , Policy Strategy and ... across the Strategic Planning & External Engagement team, reporting to the Executive Director , Policy Development & Strategy . The Associate Director will… more
- American Water (Camden, NJ)
- …and ensuring functional excellence. Service, Parent and Affiliate Company Rate and Regulatory Legal Strategy : * Support the development and effective ... and/or state regulatory and operations counsel to advance the Company's strategy to recover Service and Parent Company costs Cross Functional Legal Strategy… more
- Pfizer (Collegeville, PA)
- …evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language and ... input and requirements of relevant Pfizer Oncology stakeholders (eg, Medical Strategy , Field Medical, Clinical Development, Scientific Affairs , Research, etc.)… 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)
- …for the programs (Clinical Development Plan: manufacturing, pre-clinical, CDP, dose-finding, regulatory strategy , publication, pricing/market access) + A modern ... Director , Clinical Statistics Date: Sep 19, 2024 Location:...strategic and scientific leadership to the clinical development, registration strategy , submission, health authority interactions, and medical affairs… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the development ... and implementation of labeling content and strategy of multiple assigned products in various stages of...assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- ThermoFisher Scientific (Wilmington, DE)
- …assist different departments, such as marketing, sales, manufacturing, quality and regulatory affairs . You will also collaborate with healthcare professionals, ... experienced individual to join our team as Global Medical Director , Allergy on the Medical and Scientific Affairs...(IDD). This role is responsible for developing a global strategy to drive growth within the medical domain of… 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
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Associate Director , BSD Human Resources Job Profile Title Associate Director C, Human ... of Business Services (BSD) is looking for an Associate Director of Human Resources with deep experience influencing and...staff. + Play a key role in labor relations strategy , maintaining strong relationships with three labor unions, and… more
- CSL Behring (King Of Prussia, PA)
- …will 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 partners, and… more
