- J&J Family of Companies (Spring House, PA)
- …We are searching for the best talent for a **Senior Manager/Associate Director ** , ** Regulatory Medical Writing** within our Integrated Data Analytics ... Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs , Medical Communications, Performance Measurement, Quality Validation,… more
- Veterans Affairs, Veterans Health Administration (Wilkes Barre, PA)
- …the Medical Directors and Program Managers of assigned services is responsible for the quality of care provided by the program, for the productivity of the program ... VAMC mission. In addition to observance of Federal National and Local regulatory , policy, and accreditation requirements governing this Health Care System, this… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …of a Allied Health Professional Duties include but not limited to: Research and Quality Assurance: 1. Conduct research relevant to the mission of the MIRECC which ... precision mental health care. 2. Provides consultation to investigators on all regulatory oversite of the research portfolio and in particular clinical trials.… more
- University of Pennsylvania (Philadelphia, PA)
- …Job Profile Title Clinical Research Regulatory Specialist C Job Description Summary Regulatory Affairs as a field is concerned with ensuring that clinical ... is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface...to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Senior Director , Medical Communications, CNS directs and provides strategic...accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position… more
- Penn Medicine (Philadelphia, PA)
- …this regard. Provides ongoing continuing education and skill validation of clinical staff. Quality , Patient Safety, and Regulatory Affairs : Partnership with ... the Vice Chair for Quality , Medical Director of Ambulatory Operations, and departmental Ops team on...Health System Requirements. In conjunction with the Vice-Chair of Regulatory Affairs , develop programs that enhance the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …the Senior Director to ensure timely and compliant submission of high- quality abstracts, posters, and manuscripts in line with Good Publication Practices (GPP) ... The Associate Director , Scientific Communications manages the execution of the...accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- The Associate Director , Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and tactical ... through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional cross-functional stakeholders… 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 ... clinical operations quality systems, document management, and quality control processes. At all times the Director...clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that… 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