Regulatory Medical Writer

Prerequisites Minimum of BS/BA degree in science
(MS/PhD/PharmD preferred) with approximately 1-3 years of regulatory writing and submission experience

Responsibilities will include, but are not limited to, the following:
1. Author, co-author, critically edit, and format regulatory documents including protocols, CSRs, Investigator Brochures, briefing documents, NDAs, MAAs, INDs, DSURs, and other regulatory submissions;
2. Author, co-author, and critically edit publications including abstracts, posters, slide presentations, manuscripts, and review articles;
3. May manage overall medical writing timelines for assigned projects;
4. Serve as the lead on assigned projects and advise teams on content, format, and styleguide requirements for documents;
5. Support the development of medical writing processes, SOPs, work instructions, and document quality control;
6. Maintain subject area expertise relating to the client’s investigational products, disease indications, and regulatory and publication guidelines;
7. Willingness to perform miscellaneous job-related duties as assigned and accept new responsibilities as needed.

Additional qualifications may include:
1.Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses;
2. Excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines;
3. Effective collaborator with ability to foster strong working relationships and build consensus among colleagues on cross-functional teams;
4. Initiative and ability to handle a variety of projects simultaneously;
5. Excellent interpersonal and communication skills;
6. Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT;
7. Expert user of Microsoft Word, PowerPoint, and Excel; and
8. Tech-savvy with the initiative and drive to support the implementation of softwaresolutions to streamline medical writing processes