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Medical Writer

Edison-New Brunswick Metro Area, NJ

Post Date: 08/31/2017 Job ID: JN -082017-19932
Medical Writer
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

Responsibilities will include, but are not limited to, the following:
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 for Orphan Drug Designations
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
Complete required training on time

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