Senior Regulatory Medical Writer Clinical Trials Job in Jeevan Scientific Technology Limited

Senior Regulatory Medical Writer Clinical Trials

Jeevan Scientific Technology Limited 4+ weeks ago

Hyderabad, Telangana
Not Disclosed
Full-time
Permanent

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Job Summary

RMW serves as the regulatory lead representative on project teams by partnering with the JSTL outsourcing and operational teams including functional area contributors (eg, Clinical, Data Management, etc.) to prepare a high-quality, clearly-messaged documents founded in regulation and supported by the science. These documents include but not limited to Clinical Study Reports (CSR), Clinical Summaries, Clinical Responses, and Protocol Summaries for submission to the sponsor and/or HAs.
Must be highly competent to understand the Clinical Trial Protocol elements including study designs, data analysis, timelines and patient recruitment. Coordinate the review, approval, QC, and other appropriate functions involved in the production of regulatory projects.
Arrange and conduct review meetings with the team.
Independently resolve document content issues and questions arising during the writing process.
Prepare scientific communications for external publication in peer-reviewed journals and presentations at scientific congresses. These documents include manuscripts, abstracts, posters and oral presentations
RMW provides leadership and project management expertise for ongoing programs and/or projects and initiatives.
Ensure accurate and timely completion/delivery of information and review of regulatory submissions to the sponsor or its designee.
Communicate regularly with JSTL leadership on timeline/milestone progress for any assigned program.
Assess resource needs as timelines progress and communicate any addition resource requests to department management team.
Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH, CDSCO) and other governing bodies by following applicable divisional guidelines, templates, and standard operating procedures (SOPs).
Proactively identify and implement tactical process improvements.
Mentor and provide guidance and oversight to support staff including other participating writers and/or external vendor resources and agencies.