- Merck (Upper Gwynedd, PA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- J&J Family of Companies (Malvern, PA)
- …to partner with the various functional areas (Local Operating Companies, Regulatory Affairs , Manufacturing Plants, Finance, Graphic Services, Affiliate Services, ... + Influences and collaborates with Operating Companies, Manufacturing and Technical Operations, Regulatory Affairs , Quality Assurance and Compliance to develop a… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Sumitomo Pharma (Harrisburg, PA)
- …budget for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs to ... submissions, clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory requirements. **Key… more
- Merck (Upper Gwynedd, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more} **Preferred… more
- Penn Medicine (Philadelphia, PA)
- …education and skill validation of clinical staff. Quality, Patient Safety, and Regulatory Affairs : Partnership with the Vice Chair for Quality, Medical ... alignment with Health System Requirements. In conjunction with the Vice-Chair of Regulatory Affairs , develop programs that enhance the clinical decision-making,… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... (T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+… more
- UPMC (Williamsport, PA)
- …This full-time position involves managing clinical operations, quality management, regulatory affairs , continuing education, and fiscal responsibilities. The ... programs. + Seek approval for Continuing Education Credits and maintain CE records. Regulatory Affairs Management + Coordinate regulatory compliance… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices;… more