Medical Writing Job Opening

Director/Associate Director, Medical Writing - Medimmune, Gaithersburg, MD


Major Duties and Responsibilities (including supervising others):

• Under minimal or no supervision, writes and edits clinical study reports, protocols, informed consent forms, and other clinical and regulatory documents including Investigator Brochures and annual reports as needed.
  
• Leads the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed.
  
• Manages and develops direct reports, including performance reviews and regular 1:1 meetings.
  
• Identifies and manages contract writers as needed.
  
• Provides critical review of clinical regulatory documents from direct reports.
  
• Provides resource projections for preparation of clinical regulatory documents within therapeutic area.
  
• Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
  
• Assists in or leads the preparation or revision of SOPs, WPDs, and document templates.
  
• Participates in clinical project team meetings as needed.
  
• Participates in or leads other cross-functional team meetings and standards committees.
  
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.

Experience:

• 6+ years experience writing clinical regulatory documents including clinical study reports.
  
• Previous supervisory experience with direct reports or contract writers required.
  
• Pharmaceutical industry experience required.
  
• Background in biologics a plus.

Special Skills/Abilities:

• Experience writing and editing clinical regulatory documents.
  
• Ability to critically analyze and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
  
• Excellent writing, editing, attention to detail, and verbal communication skills.
  
• Proficiency in Microsoft Word is essential.
  
• Familiarity with CTD, ICH, GCP, and other standards.
  
• Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.

Job Complexity: Medium to High

Supervision: Low to None

If you are interested in this position, apply online at www.medimmune.appone.com and search for Req 01038.