- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...the development teams. ⦁ Develop and communicate effective CMC regulatory strategies for development and post marketing submission… more
- Merck (North Wales, PA)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...have an external business partner. + Coordinates the preparation, submission and follow-up contact with regulatory agencies… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Associate Director , Student Affairs , Graduate Programs (Department of Radiation Oncology) Job ... Profile Title Associate Director C, Student Services, Graduate Programs Job Description Summary...optimal communication across stakeholders. Responsibilities will also include providing regulatory support and oversight for the global and newly… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Director , GRO Regulatory Project Management and be a part of the Global Regulatory Affairs Team. **How you will contribute:** + As Associate Director , ... process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project… 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 ... authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on...laws (with a focus on FDA), regulations, guidances and regulatory submission routes available for new study… more
- Pfizer (Collegeville, PA)
- …vaccines. **What You Will Achieve** You will represent Pfizer as anApprovalLiaison in the regulatory affairs team. You will play the critical role of providing ... strategic regulatory expertise as Global regulatory representative to Product Team(s). As a Director...Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs… more
- Bristol Myers Squibb (Trenton, NJ)
- …Ph.D., MD, PharmD, MS, or BS **Experience Requirements** Significant experience in regulatory affairs (eg > 4-7 years) **Key Competency Requirements** Required: ... submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content...strategy liaison input. + In collaboration with the global regulatory team (GRT), develop global submission plans… more
- Teva Pharmaceuticals (West Chester, PA)
- …as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, ... key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the… more
- University of Pennsylvania (Philadelphia, PA)
- …with community partners, making scientific presentations, and creating manuscripts for submission to peer-reviewed journals. The Director is a member ... wellness programs and resources, and much more. Posted Job Title Research Project Director Job Profile Title Manager Research Project C Job Description Summary The… more
- Universal Health Services (King Of Prussia, PA)
- …Nursing, Admissions, Business Development, Process Improvement, Finance, Clinical Services, and Regulatory Affairs that effectively drive patient care outcomes. ... 24 bed expansion planned for 2026. UHS is currently recruiting for the Executive Director for expanded inpatient program at Altru Health System in Grand Forks, ND.… more
- University of Pennsylvania (Philadelphia, PA)
- …with principal investigators to discuss and advise them on financial and regulatory issues related to their new proposals and as assigned existing grants/portfolios. ... of effort reports. Participate in specific projects, including the annual budget submission . Work on the more complicated grants including clinical research grants… more
- University of Pennsylvania (Philadelphia, PA)
- …departments and outside parties. The Manager position will report directly to the Director of Research Operations for Dermatology. The Manager will work closely with ... the Director in overseeing aspects of dermatological disorders clinical research...operations of the clinical trials, including study enrollment, adherence, regulatory compliance, timely completion of project milestones, supervision of… more
- University of Pennsylvania (Philadelphia, PA)
- …of Dermatology. This role will be responsible for the preparation, review, and submission of sponsored program proposals for submission to sponsors. This ... award duties include award set up and management for financial and regulatory compliance, meeting regularly with investigators for expense reporting and projects,… more
- University of Pennsylvania (Philadelphia, PA)
- …the School's research mission. Manage and coordinate the electronic proposal submission process for Principal Investigators; maintain knowledge of complex processes ... progress, and ensure accuracy. Develop standard to complex budgets; ensure regulatory and administrative compliance with sponsor, School and University policies and… more
- University of Pennsylvania (Philadelphia, PA)
- …with grant proposal preparation, creating grant templates and other related documents including submission of grants via ASSIST, PennERA & other grant submission ... these grants. + Review granting agency regulations, inform investigators of regulatory requirements and ensure compliance. + Prepare & maintain confidential… more
- University of Pennsylvania (Philadelphia, PA)
- …Myeloma Research Team and indirectly report to the CRU Central - Associate Director of Clinical Research Operations. The successful candidate will work closely with ... selection, prioritization of the team's work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive… more
- University of Pennsylvania (Philadelphia, PA)
- …Research Project Manager B Job Description Summary This position will report to the Director of Clinical Research and oversee all aspects of the Oto portfolio of ... clinical and translational research projects. This oversight includes assisting the Director in developing the department's short and long-term research strategy,… more
- Veterans Benefits Administration (Philadelphia, PA)
- …and Program Analyst position is located with the Department of Veterans Affairs - Veterans Benefits Administration Insurance Claims Division located in Philadelphia, ... of production and man-hour reports prepared by Supervisory Insurance Specialists, for submission to the Division Chief. Establish study methods and techniques to be… more
- Universal Health Services (Philadelphia, PA)
- …to: Nursing, Admissions, Business Development, Process Improvement, Finance, Clinical Services, Regulatory Affairs that effectively drive patient care outcomes + ... metrics are achieved through sound clinical processes following accreditation and regulatory agency guidelines. + Recruit physicians and staff in targeted specialty… more
- University of Pennsylvania (Philadelphia, PA)
- …Medicine on Demand clinicians (PMOD), the PI and Co- PI, program manager, and CRS Director . The SUN will be part of a partnership with the Philadelphia Department of ... process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate including initial submissions, amendments, continuing reviews,… more