- Merck & Co. (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... Brochures before release from our company to external agencies and investigators.Represents Global Regulatory Affairs (GR) within internal committees to… more
- 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)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... forecasting and analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast… more
- Merck & Co. (North Wales, PA)
- …resources to address the opportunities.Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), ... Job DescriptionJob Description:The Associate Director , Marketing, HPV Scientific Strategy plays a critical...for a One Company approach.Collaborating with Program Leads, Medical Affairs and Global Expert Management & Strategy… more
- Merck & Co. (North Wales, PA)
- …development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… 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 (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
- J&J Family of Companies (Spring House, PA)
- Associate Director , CMC Regulatory Affairs ...product and is in alignment with the strategies of global regulatory affairs , the therapeutic ... **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs . This... strategy through partnership and communication with Therapeutic Area Regulatory Affairs ( Global Regulatory… 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
- 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
- Merck (North Wales, PA)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... + Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS),… 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
- 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:** Oct 13, 2024 **Location:**...internally as clinical development expert for global regulatory interactions; collaborate with Regulatory Affairs… more
- Teva Pharmaceuticals (West Chester, PA)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** The Senior Director ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… 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
