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Director, Phase IV Studies

Medimmune-Gaithersburg, MD, 20877

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 ...
 

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Description of Position „X Responsible for the adaptation of transferred information for Phase I through Phase III processes from Development (Cell culture and Purification) to Clinical Manufacturing. Involved in the creation of production documentation, evaluation of process fit to facility and schedule, analysis of production data, identifying trends and researching causes for variations in production processes. Works closely with other groups within MedImmune (Development, QC, QA, Engineering, Materials Management, Validation) and acts as facilitator to initiate change. Principal Duties ...
MedImmune, LLC | Gaithersburg, ME, 20878 | 1-2
Position Title: Medical Writer I/II Location: Gaithersburg, MD Req #: 01248 Position Summary: Major Duties and Responsibilities: • Under supervision, writes and edits document shell and safety narratives for clinical study reports; protocols, protocol amendments, informed consent forms, and other clinical and regulatory documents including Investigator Brochure updates and annual reports. • Under supervision, incorporates and addresses comments from multiple reviewers into successive drafts of clinical regulatory documents. • Provides QC support for clinical regulatory documents as needed (...
 
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