- Sumitomo Pharma (Harrisburg, PA)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health.… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... and regulatory standards. This position resides in the Medical Affairs Gastroenterology Therapeutic Area (TA) Team which is responsible for developing,… more
- Organon & Co. (Plymouth Meeting, PA)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... three years of experience in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked… more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- J&J Family of Companies (Horsham, PA)
- …interactions with the global functions including clinical R&D, translational medicine, regulatory affairs /labelling, and global medical safety. This includes ... for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs ...providing data and subject matter expertise for regulatory requests. + Serve as a key driver of… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …successful candidate will work closely with Clinical Operations, Quality Assurance, Regulatory Affairs , and the Program Management team. Strong cross-functional ... team leadership and project management skills are essential requirements of the role. This position will report to the General Manager. **The Role:** + Manage and mentor a diverse operations team, including planning, logistics and inventory management, to… more
- UPMC (Farrell, PA)
- …in the administration of contrast agents used during treatment localization. + Regulatory Affairs Management:Participates in regulatory compliance activities ... and maintains continuous departmental readiness for inspections and surveys.Follows all radiation safety standards.Wears radiation monitoring badge and ID badge at all times.Remains HIPAA compliant at all times. Completes clinical competencies annually as… more
- Merck (West Point, PA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs , clinical operations, and CMC teams. + **Reporting & ... on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project… more
- Talen Energy (Berwick, PA)
- …a management position in Site Support, NOS/Quality Assurance, Emergency Preparedness, Regulatory Affairs /Performance Improvement or INPO Loanee.** **Note:** You ... accredited programs.** + **Maintaining Operations Training Programs that meet Nuclear Regulatory Commission (NRC) federal rules and laws.** + **Maintaining a working… more
- CSL Behring (King Of Prussia, PA)
- …**Qualifications & Experience Requirements** Bachelor's degree required. *8+ years of Regulatory Affairs experience, with at least 6+ years specifically ... Global Advertising and Promotion is responsible for developing and overseeing the regulatory strategy and compliance of promotional and non-promotional with a global… more