Manager, Regulatory Writing
Posted on Apr 5, 2021 by Medpace Holdings, Inc.
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Manager, Regulatory Writing to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Integral member of the team responsible for departmental hiring, training, management, and evaluation of Medical Writers and other support personnel;
Supports the Medical Writing group in the development of IND, NDA, and MAA components across a variety of therapeutic areas;
Acts as a primary writer and/or project manager for key documents or projects;
Works with global Medical and Regulatory experts to understand, interpret, and apply the clinical considerations and regulatory strategies pertinent to document development;
Works with Sponsors and internal departments to develop timelines for writing projects; and
Involved in determining and presenting the scope of work for bid proposals.
Master's degree or PhD with at least 5 years of medical writing experience or Bachelor's degree with at least 7 years medical writing experience;
Previous supervisory experience required;
Strong computer skills, project management skills, and a high attention to detail;
Strong communication skills (both written and oral);
Strong analytical and problem-solving skills;
Experience writing US and/or EU regulatory documents preferred;
Scientific background preferred.