- 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 (North Wales, 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
- 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
- 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
- Merck (North Wales, PA)
- …to address the opportunities. + Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), Center ... **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… 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
- 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
- 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 Oncology Solid...propositions in assigned areas of responsibility. Ensures compliance with regulatory , legal, and commercial regulations (for example Contract Pricing… 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