Regulatory Affairs Operations Officer (Project Manager)

12 Nov, 2020


Regulatory Affairs Operations Officer (Project Manager)

Harvard University
Boston, MA

Harvard Catalyst | The Harvard Clinical and Translational Science Center (CTSC) facilitates clinical and translational research throughout the Harvard Schools and 16 clinical affiliates of Harvard Medical School, and across the nation, by lowering barriers to research and providing tools, training, and technologies. Harvard Catalyst’s Regulatory Foundations, Ethics, and Law Program minimizes the regulatory burdens for investigators and promotes cooperation and interoperability. Learn more about the Program at to the Director of Regulatory Affairs Operations, the Regulatory Affairs Operations Officer works to build consensus and partnerships as part of an interdisciplinary, cross-institutional team made up of content experts from diverse backgrounds and institutions. The Officer is responsible for representing the Program and for maintaining and providing project management to a number of Regulatory committees across multiple disciplines. The Officer will also be actively engaged in a number of programmatic deliverables and participate in various national initiatives.

The Officer works with leadership and the committee chairs to define project deliverables and the responsibilities of project team members and establishing and implementing the overall project work plan and timeline. The Regulatory Affairs Operations Officer will track and monitor progress to assure each project is delivered on time and at the highest quality and will work collaboratively and creatively to address roadblocks and respond to shifting priorities.

The ideal candidate will work effectively and productively with various stakeholders from the affiliated Harvard institutions and beyond. Candidate should have high executive function, excel at consensus building, and possess the ability to manage without authority and ensure committee members feel invested in and motivated to complete identified deliverables.

Basic Qualifications

B.S. or B.A., three + years of administrative or project management experience

Additional Qualifications and Skills

  • Working knowledge of theories, principles and concepts typically acquired working in a clinical research setting, academic research, or health care environment related to research administration, and institutional review boards
  • Understanding of research compliance and Human Research Protection Programs, or research regulations preferred
  • Excellent verbal communication skills and writing skills
  • Demonstrated experience working with multiple internal and external constituencies to build consensus in setting agendas and implementing approaches in large decentralized setting
  • Proactive, time-sensitive, results-driven approach to carrying out assigned and assumed responsibilities, and possess the ability to handle multiple, often competing tasks, with grace and good humor to reach common group goals
  • Flexibility and adaptability to changing priorities
  • Comfort with public speaking
  • Familiarity with REDCap, Qualtrics, or other survey tools a plus

Additional Information

This is a term appointment with the end date of April 30, 2022, with the possibility of renewal contingent on funding.

Harvard offers an outstanding benefits package including:

Time Off: 3 – 4 weeks paid vacation, paid holiday break, 12 paid sick days, 11.5 paid holidays, and 3 paid personal days per year.

Medical/Dental/Vision: We offer a variety of excellent medical plans, dental & vision plans, all coverage begins as of your start date.

Retirement: University-funded retirement plan with full vesting after 3 years of service.

Tuition Assistance Program: Competitive tuition assistance program, $40 per class at the Harvard Extension School and discounted options through participating Harvard grad schools.

Transportation: Harvard offers a 50% discounted MBTA pass as well as additional options to assist employees in their daily commute.

Wellness options: Harvard offers programs and classes at little or no cost, including stress management, massages, nutrition, meditation, and complementary health services.

Harvard access to athletic facilities, libraries, campus events, and many discounts throughout metro Boston.

The Harvard Medical School is not able to provide visa sponsorship for this position.

Learn more here

Job posted: 2020-11-12