- Eisai, Inc (Philadelphia, PA)
- …all MSL activities. Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs . Training/Education Resource Maintain and ... Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the...of institutions focused on AD preferred 3-5 years industry/ clinical research / related experience in a scientific… 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
- 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
- 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
- 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
- Bausch + Lomb (Trenton, NJ)
- …degree or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B...cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+ ... this role. + Stay abreast of the latest advancements, research , and publications within the assigned disease areas in...evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …diverse backgrounds and beliefs - Adaptability: Flexibility in adapting to changing clinical situations, work schedules, regulatory environments, and advances in ... includes in-person and telehealth Veteran encounters. Although the Hospice Clinical Director is the primary provider in the Hospice...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). You may be required… more
- University of Pennsylvania (Philadelphia, PA)
- …all applicable institutional regulatory review committees. In collaboration with clinical research teams and investigators he/she will prepare, and process ... call home for work and play. Posted Job Title Clinical Research Specialist Job Profile Title Temporary...Affairs Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and… more
- University of Pennsylvania (Philadelphia, PA)
- …reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Assist with creation of master trial ... programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B Job Profile Title...data and regulatory files per GCP.Work with Regulatory Affairs Specialist to prepare for audits,… more
