Medical Writer - FDA/eCTD

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.

RESPONSIBILITIES:

• 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

REQUIRED QUALIFICATIONS:

• 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