GDIT's Military Health team is hiring a Medical Writer to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring.
Write, review, edit, and advise on the development of documents and dossiers in electronic Common Technical Document (eCTD) format, to include IND applications, master files, investigational new device applications, biologics license applications, new drug applications, annual reports, information amendments, clinical protocols and study reports, investigator’s/investigational brochures, FDA meeting requests and background materials, responses to FDA requests for information, target product profiles, clinical development plans, manuscripts, white papers, 510k pre-market notifications, and to a lesser extent pre market approvals and Environmental Protection Agency registration packages.
Use eCTD format, MS Word, and applicable templates and standards to produce documents and dossiers compliant with FDA and Office of Regulated Activities (ORA) regulations and standards.
Lead and manage writing projects
Track and meet deadlines for writing projects
Attend, participate in, and organize meetings
Provide routine reports and updates to team members, project managers, and Government leaders
Provide subject matter expertise on regulatory documentation and version control
Participate in special projects as required
Bachelor’s degree in science field or a related discipline, or the equivalent combination of education, professional training, or work experience.
5 years of regulatory or medical writing experience.
Experience writing investigational new drug (IND) application documents in Common Technical Document (CTD) format
Proven editorial and MS Word formatting skills
Project management skills, including the ability to be proactive, multi-task, word collaboratively in a team environment, and meet deadlines
Knowledge of current regulatory guidelines related to regulatory communications
The ability to work independently and as part of a team and oversee the activities related to US Food and Drug Administration (FDA) dossier preparation
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust)
WHAT GDIT CAN OFFER YOU:
Challenging work that makes a real impact on the world around you
Internal mobility team dedicated to helping you own your career
401K with company match
Diverse, highly collaborative teams
Professional development, education assistance, certification and training opportunities
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.