Medical/Regulatory Writer - US based preferred

Hello - I am looking for a skilled Medical/Regulatory Writer.

MUST have following skills:

*Minimum of BS/BA degree in science (Masters or PhD preferred) with at least 5 years of regulatory writing and submission experience

*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

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

MUST SUBMIT samples of Recent experience writing regulatory submission documents, eg, CSRs, CTD summaries or clinical overview, briefing books

ADD the word "MEDICAL" to the top of your message so that I know you have read this message in its entirety. If you do not, I will delete your message for sending spam.

Навички: Написання медичних текстів, Медицина, Розробка технічних документів, Здоров'я

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Про роботодавця:
( 8 відгуки(-ів) ) Astoria, United States

ID Проекту: #25590268

10 фрілансерів(-и) у середньому готові виконати цю роботу за $360


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