Reporting 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.
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
B.S. or B.A., three + years of administrative or project management experience
Internal Number: 52644BR
About Harvard Medical School
Harvard Catalyst | The Harvard Clinical and Translational Science Center (CTSC) facilitate 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 http://catalyst.harvard.edu/programs/regulatory/