Medical Writer - (Groton, CT)

Title: Scientist " Medical Writer Time Period: 12 mons Location: Madison, NJ Job details: The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of 1 or more drug products. This will be achieved by applying issue solving abilities, functional literacy and ability in document preparation. The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, REMS, key sections of the Investigators Brochure, the Annual Safety Report and regulatory briefing documents. Achieved through application of team-working approaches this individual will create and foster an environment of partnership with other members of product teams.