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.
- 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.
- 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.