Director PRMS & Regulatory Affairs

H. Lee Moffitt Cancer Center

Tampa, FL

ID: 7069014 (Ref.No. hlj_26938)
Posted: August 20, 2020
Application Deadline: Open Until Filled

Job Description

Director PRMS & Regulatory Affairs

Moffitt Cancer Center (MCC), an NCI-designated comprehensive cancer center in the state of Florida, and the #11 ranked Best Hospitals for Cancer on U.S. News & World Report, 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.

 Position Highlights:

  • Directs and oversees the regulatory infrastructure for Clinical Research at Moffitt. 
  • Responsible for the PRMS under the CCSG, which includes policy development, reporting and administrative leadership.  
  • Responsible for long and short term planning and directing of regulatory activities.  
  • Represents Moffitt on local, regional and national committees.

Ideal Candidate:

  • 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.

Responsibilities:

  • Will provide long term strategic planning on clinical trials research and trial feasibility.
  • Directs the development of policies and procedures for clinical trial research and assures appropriate approval from institutional compliance committees and funding agencies.
  • Prepares reviews and maintains departmental reports on clinical research.
  • In collaboration with other clinical 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 of seven (7) years of progressively responsible regulatory/quality management experience; specific oncology regulatory experience preferred.
  • At least 5 years in 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.



 

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