- IQVIA (Philadelphia, PA)
- **Position Overview:** IQVIA is seeking an experienced Associate Clinical Project Management Director/Trial Delivery Manager (TDM) to lead and coordinate global ... role that may require some travel IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life… more
- University of Pennsylvania (Philadelphia, PA)
- …Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description Summary With the oversight ... Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities… more
- Sumitomo Pharma (Harrisburg, PA)
- …understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical ... Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) ...of the Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line… more
- Sumitomo Pharma (Harrisburg, PA)
- …of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical ... requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and...Health Authorities + Assist with development of the global regulatory functional plan through research , review and… more
- Penn Medicine (West Chester, PA)
- …to finish working closely with the Abramson Cancer Center One Penn Medicine Cancer Clinical Research (ADD OCCR) Regulatory coordinators to manage, review, ... Team to oversee all aspects of the oncology clinical research portfolio. This employee will oversee...Director will also work closely with major internal (PI, Regulatory , Legal, Budget, Finance, Billing Compliance, Infusion, Pharmacy) and… more
- University of Pennsylvania (Philadelphia, PA)
- … Trials in overseeing all aspects of the Renal Clinical Research Unit (RCRU), including operations, regulatory processes, staff development, and financial ... the continued growth and expansion of the Division of Renal-Electrolyte and Hypertension's clinical research portfolio, the Associate Director for Clinical … more
- Bausch + Lomb (Harrisburg, PA)
- …clinical , labeling, adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical , labeling,… more
- Penn Medicine (Philadelphia, PA)
- …on strategies and/or actions necessary to improve compliance to include regulatory , clinical performance, and/or safety outcomes. Develops, maintains, and ... mission of providing the highest level of care to patients, conducting innovative research , and educating future leaders in the field of medicine. Working for this… more
- Organon & Co. (Plymouth Meeting, PA)
- …the product lifecycle. + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, ... timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- West Pharmaceutical Services (Exton, PA)
- …and planet through our sustainability efforts. **Job Summary** The Director of Regulatory Affairs provides strategic leadership and project management to ensure ... and compliance. The Director is also responsible for personnel management, supporting clinical programs, and driving continuous improvements in regulatory and… more