Principal Medical Writer I

About the Organization My company shares my passion for helping to improve human health around the world." "This is My MedImmune." Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities• that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Description Title: Principal Medical Writer I Location: MD, Gaithersburg - Corporate Headquarters Req: 02041 Position Summary: 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. ? Leads the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed. ? Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts. ? Negotiates timeline development for preparation of clinical regulatory documents. ? Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents). ? Reviews case report forms, statistical analysis plans, and data tables and listings for content and format. ? Assists in or leads the preparation or revision of SOPs, WPDs, and document templates. ? Participates in clinical project team meetings ? Participates in or leads other cross-functional team meetings and standards committees. ? Provides mentoring to junior writers. ? Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards. Position Requirements Experience: ? 6+ years experience writing clinical regulatory documents including clinical study reports. ? 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: None to Low (supervision required, level of independence) Educational Requirements Education: ? Requires an advanced degree in a scientific discipline or a bachelors degree with equivalent work experience. Company Info None Specified

Please refer to job code 02041 when responding to this ad.

Category:	Communications
	> Writer
Location:	Gaithersburg, MD
County:	Montgomery County
ZIP Code:	20877
Pay Rate:	Open
Job Terms:	full time
Company:	MedImmune Inc.
Phone:	email only please
Fax:	email only please