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Medical Writer

New Jersey All, New Jersey

Post Date: 09/13/2017 Job ID: JN -092017-19996 Industry: Medical Writing - Clinical
Author regulatory submission documents, eg, CSRs, CTD summary documents (2.7.3, 2.7.4, possibly 2.7.1, and 2.7.2), and Clinical Overviews (2.5), Integrated Summaries of Efficacy and Safety, Pediatric Investigation Plans, Proposed Pediatric Study Requests, Requests of Product Specific Waivers, and applications
Prepare IBs (FIH/other, IB updates)
Provide direction to team on content and optimal data presentation/summarization in the document
Develop the strategy for document preparation and the document review processes, including the management of timelines
Facilitate document review meetings and discussions
May act as medical writing lead on submissions or new programs, including early development programs
May contribute to Clinical Trial Data Sharing activities, including act as the lead for team review and redaction of private patient and/or confidential commercial information from documents and/or review documents prepared for redaction
Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 5 years of regulatory writing and submission experience
Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books
Experience in oncology, hematology, and/or inflammation and immunology therapeutic areas preferred
Ability to work with complex projects, within cross-functional teams, and under tight timelines
Requires attention to accuracy, quality, and adherence to format and stylistic requirements
Excellent grammatical and communication skills, both written and oral
Expertise in MS WORD

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