- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director ... for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Merck & Co. (North Wales, PA)
- …Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting ... Global Liaison.Participates as an active member on the Global Regulatory Team. They will attend cross-funnal... Affairs and Clinical SafetyJob Level/ Grade- 400Reports toGlobal Regulatory Liaison, Executive Director or Associate Vice… more
- Merck & Co. (North Wales, PA)
- …for the strategic planning and execution for product development and worldwide regulatory submissions. Lead a team of statisticians and the statistical ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we ... cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Director May Be… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Aequor (West Chester, PA)
- …and procedures.Conducts other projects and tasks as assigned.Reports To: Director , Medical CodingEducation and Knowledge Requirements:Sr. Medical Coding Specialist - ... skills and leadership qualities.Proven success working in a virtual, global , and multi-cultural environment.Ability to multitask, prioritize and work effectively… more
- Merck (North Wales, PA)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... their assigned projects. **Position Description** The Principal Scientist / Director responsibilities include but are not limited to: +...+ Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- J&J Family of Companies (Harrisburg, PA)
- Director , Global Regulatory Leader (GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global ... more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead...exist + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Merck (Upper Gwynedd, PA)
- …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory...submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a US Lead , Global Regulatory Policy and Innovation where you will anticipate, ... leader and valued partner in prioritized areas of regulatory policy. Provide strategic and directional insight to product... & Policy Innovation, you will report to Executive Director & US Head, Global Regulatory… more
- Merck (North Wales, PA)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary,...targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product… more
- Merck (Philadelphia, PA)
- … Regulatory Affairs and Clinical Safety **Job Level/ Grade** 400 **Reports to** Global Regulatory Liaison, Executive Director or Associate Vice President, ... encompass all aspects of planning and implementation of a global regulatory strategy and regulatory ...reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses… more
- Lilly (Philadelphia, PA)
- …people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory activities for ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana....for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Pfizer (Collegeville, PA)
- …GCC operates across all Digital functions at Pfizer and supports all business units. As ** Director , Global Command Center Lead ** , you will develop and ... Center, aligning with organizational objectives and IT service management goals. You will lead a global team of Situation Analysts and Managers, ensuring… more
- J&J Family of Companies (Harrisburg, PA)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...plan, assessment aid) documents is preferred. + Knowledge of global regulations, regulatory timelines, guidelines, and … more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and… more
- J&J Family of Companies (West Chester, PA)
- Senior Director Strategy, Innovation and Deployment Leader (SI&D), Johnson & Johnson MedTech - 2406214042W **Description** **Senior Director Strategy, ... (SI&D) Leader within Orthopaedics Supply Chain** is expected to lead the development and implementation of operational strategies and objectives across the… more
- Fujifilm (Harrisburg, PA)
- **Overview** The Director of Global QC Materials is accountable for high GMP service and support level within QC as well as with applicable stakeholders outside ... Genki. Responsible for driving development and implementing the FDB global QC material strategy, the Director of...requirements, assessments and testing strategy across the Company + Lead and develop a team responsible for driving, supporting,… more
