Tuesday, August 26, 2008

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.

2 comments:

Jaya said...

I want to start as a Medical Writer. How shold I go about it and where to look for vaccancies

diego said...

Read this post:
http://medicalwriter.blogspot.com/2007/03/so-you-want-to-be-medical-writer.html

And keep an eye on this blog for job postings. You can also look at Monster.com and similar sites.