- Merck & Co. (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Pain, Neuroscience, Neuroscience Research , Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance, Scientific… more
- Merck & Co. (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Merck & Co. (Upper Gwynedd, PA)
- …(including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout sites in the USA, UK… more
- Merck & Co. (North Wales, PA)
- …Affairs , Manufacturing, Global Marketing, Global digital data and analytics, PDT/ Research & Development, Policy, Regulatory , Legal/Compliance teams, and other ... skills and executive presence Understanding of the US commercial and regulatory requirements Marketing Communications and Market Research experience Required… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- CSL Behring (King Of Prussia, PA)
- …active inputs from key stakeholders in medical affairs , sales, commercial development, clinical research and development, regulatory affairs , etc. ... Operations input is provided in the development of Target Product Profiles, clinical research protocols and Target Labeling copy through appropriate channels… more
- Organon & Co. (Plymouth Meeting, PA)
- … Epidemiology and Economics will report to the headquarters Director of Medical Affairs Outcomes Research . Focusing on Dermatology, in this role, you will ... be responsible for establishing/continuing economic Modelling research programs that include developing, design and delivering health economic modelling projects.… more
- Organon & Co. (Plymouth Meeting, PA)
- …work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing ... 1 to 2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external (contract research organization [CRO], bioanalytical… more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... and approval in one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... and approval in one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… more
- Parexel (Trenton, NJ)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and ... regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies...+ Minimum of 6 years of relevant experience in clinical research including at least 2 years… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title ... Clinical Research Regulatory Specialist B Job Description Summary ...Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff… more
- University of Pennsylvania (Philadelphia, PA)
- …as the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs matters. The Associate Director for ... Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description...the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical … more
- Cardinal Health (Trenton, NJ)
- …as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implement regulatory strategies for ... **_What Regulatory Affairs contributes to Cardinal Health_**...the integrity of regulatory data used for regulatory submissions, clinical evaluations and post-market surveillance.… more
- Sumitomo Pharma (Trenton, NJ)
- …+ Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising ... and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must...individual will be responsible for leading development of all non- clinical and clinical regulatory strategies… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...Regulatory Affairs (GRA) team based in the US. He/she will...medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in… more
- Sumitomo Pharma (Trenton, NJ)
- …highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads the Regulatory ... CNS assets. **Job Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain approval for … more
- Penn Medicine (Philadelphia, PA)
- …PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and strategic direction across ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- Bausch + Lomb (Trenton, NJ)
- …Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to ... + Strong business acumen and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative ideas to promote a successful… more
