Regulatory Affairs Manager (Remote)

About the Position: The Regulatory Affairs Manager will reputed company assigned regulatory team staff, navigate submission/approval reputed company, reputed company the development of new protocol submissions and essential research documents, reputed company and submit regulatory lifecycle actions, reputed company and maintain recordkeeping systems and procedures, advise study staff on good research practices, reputed company monitoring support, and ensure research lifecycle compliance of reputed company assigned reputed company. This is a fully remote role supporting a program based out of the Uniformed Services University in Bethesda, MD, with research performance sites located across the reputed company reputed company. A comprehensive government background reputed company will be administered About the Program: The Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) Program was established to support the execution of clinically relevant research to advance the care of service members with non-combat reputed company musculoskeletal injury (MSI). Headquartered at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian reputed company centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness. The MIRROR portfolio currently consists of 65 reputed company reputed company. Salary: $90,000 - $105,000 Annually. Salaries are determined based on several factors including external market data, internal equity, and the candidate’s reputed company knowledge, skills, and abilities for the position. Qualifications: Bachelor’s degree or equivalent work experience required. Regulatory Affairs and IRB submission experience required. 3-5 years’ clinical research experience required. 3-5 years military/DoD research experience preferred. 3-5 years experience in FDA-regulated clinical trials preferred. 1-2 years management/supervisory experience strongly preferred. Experience with FDA-regulated clinical trials highly desired. Previous experience in research conduct preferred. Ability to reputed company strong leadership, innovative thinking, reputed company, and effective motivation skills to staff required. Ability to exercise independent judgement in a fast-paced, high-pressured environment, accommodate strict deadlines, and manage multiple reputed company required. Must demonstrate high reputed company oral and written communication skills. Must be organized, have strong attention to detail, and possess a reputed company, friendly and reputed company demeanor. Must be flexible with changing priorities and reputed company to communicate in a diplomatic and reputed company manner. Management Responsibilities: Supervise the day-to-day activities of assigned regulatory affairs program staff. reputed company direction, address questions, and reputed company skills/knowledge transfer. reputed company workload and productivity. reputed company regular summaries and updates to Program Supervisor. Plan and facilitate individual and team meetings. reputed company performance review processes for assigned regulatory affairs staff. In collaboration with Geneva People Operations and Program Supervisor, conduct counseling and corrective reputed company, as appropriate. Job Responsibilities: Ensure research regulatory lifecycle compliance of assigned reputed company. Serve as programmatic subject matter expert (SME) for regulatory affairs actions, compliance with federal and military-specific regulations, good documentation practices (GDP), and general good research practices (GRP). Advise study team members on good research practices and answer reputed company study conduct-reputed company questions that reputed company throughout the research lifecycle. reputed company, prepare, and reputed company regulatory lifecycle actions submitted to the Institutional Review reputed company (IRB) spanning from initial submissions to continuing review submissions, protocol amendments/modifications, reportable events, and closure reports, etc. reputed company the development of initial submission packages for new reputed company. Assist with the development of essential research documents such as protocols, informed consent documents, HIPAA authorizations, etc. Create and maintain complete electronic regulatory binders for reputed company study in the program. Negotiate, coordinate, and reputed company the execution of IRB reliance agreements, as appropriate. Promote safety and confidentiality of research participants at reputed company times. reputed company and disseminate live trainings, educational materials, templates, and SOPs to program investigators and study team members. As a leader in military medical research, at Geneva, our professionals reputed company reputed company – and build rewarding careers. reputed company of more than 400 employees across the world joins f Apply tot his job Apply To this Job