- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , Clinical Development, Regulatory , Legal, and ... the core scientific lexicon and messaging, ensuring its consistent application across all Medical Affairs materials through clear guidance to the Manager of Core… more
- University of Pennsylvania (Kennett Square, PA)
- …high-energy environment. Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise in animal ... ecosystem of advanced orthopedic surgery and the translational and regulatory sciences. We seek a Study Director ...Preference will be given to individuals with experience in regulatory affairs , GLP study directorship, and expertise… more
- Penn Medicine (Philadelphia, PA)
- …and Delaware. Reporting to the Senior Director of Government Relations and Regulatory Affairs , the Associate Director helps develop and implement Penn ... the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and...the Senior Director of Government Relations and Regulatory Affairs on strategic initiatives and short-… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …(PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs , Medical Communications, or Publications within the pharmaceutical ... functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional… more
- University of Pennsylvania (Philadelphia, PA)
- …accordance with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures ... accordance with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....plans. The Clinical Pharmacology Lead will serve as the medical monitor and/or study director responsible for… more
- Penn Medicine (Philadelphia, PA)
- …psychotherapy. (Required) + Successfully credentialed by the University of Pennsylvania, Office of Medical Affairs prior to hire date (Required) + State of PA ... leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Research Director C Job Profile Title Director C, Business and Finance, Research ... Services Job Description Summary Primary Function and Purpose: The Director of Research Administration leads and manages all financial, operational, and… more