DIR PRMS AND REG AFFAIRS
H. Lee Moffitt Cancer Center
ID: 7117576 (Ref.No. hlj_42161)
Posted: December 8, 2022
Application Deadline: Open Until Filled
Director PRMS & Regulatory Affairs
Moffitt Cancer Center (MCC), an NCI-designated comprehensive cancer center in the state of Florida, is seeking a highly motivated individual to join the Protocol Support Office as Director PRMS & Regulatory Affairs. Be part of the significant contributions to the prevention and cure of cancer which is based on compassion for our patients, an emphasis on collaboration, and a culture of scientific excellence.
Directs and oversees the regulatory infrastructure for human subjects research (HSR) at Moffitt.
Responsible for the Protocol Review and Monitoring System (PRMS) under the CCSG, which includes policy development, reporting and administrative leadership.
Responsible for long and short term planning and directing of regulatory and PRMS activities.
Represents Moffitt on local, regional and national committees.
Experience at an NCI designated cancer center with first-hand CCSG experience.
Ability to organize, negotiate, and lead the team in strategic discussions with regulatory agencies.
Be able to demonstrate strong leadership, interpersonal and communications skills (written and oral); performance tracking, mentoring, assessment, and discipline.
Well-developed project management and problem-solving skills.
Demonstrates a thorough knowledge of federal regulations for clinical research trials.
Must be able to address and navigate competing investigator, disease group, and institutional priorities in order to reach optimal solutions.
Will provide long term strategic planning on all HRS and trial feasibility.
Directs the development of policies and procedures for HSR and assures appropriate approval from institutional compliance committees and funding agencies.
Prepares reviews and maintains departmental reports on HSR.
In collaboration with other research Managers/Directors, oversees the daily operations of the Regulatory and PRMS teams.
Responsible for fiscal oversite of assigned cost centers.
Credentials and Qualifications:
Bachelor's degree; Master's degree preferred.
Minimum 7 years of progressively responsible regulatory/quality management experience with specific oncology regulatory experience preferred. At least 5 of those years should be in a management or senior regulatory role with demonstrated success in project management, interfacing with regulatory agencies and strong budget management experience.
Moffitt offers excellent salary and benefits as well as Relocation assistance.
Mission To create a Moffitt culture of diversity and inclusion as we strive to contribute to the prevention and cure of cancer. Vision Moffitt Cancer Center is recognized as the model wherein the diversity of our employees and communities is valued and supported as essential components to contributing to the prevention and cure of cancer. The cancer center is an equal opportunity employer. It is the policy of the cancer center to prohibit unlawful discrimination and harassment of any type and to afford equal employment opportunities to workforce members and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, disability, genetic information, veteran’s status or any other characteristic protected by federal, state or local law.