Position title
Sr Medical Writer & Evidence Analyst
Description
To author and review regulatory & other medical writing deliverables independently or with other Sr Medical Writer as per high-quality standards (internal & external) and within expected timelines. Support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.
Key activities
  • Authoring & reviewer of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents (excluding CTD modules) for US FDA, EMEA and rest of the world.
  • Independent authoring and review of manuscripts, abstracts, posters, evidence synthesis projects and other techno-commercial documents as needed.
  • Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements).
  • Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices (e.g. GPP).
  • Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables.
  • Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
  • Support audit readiness of the department overall. Contribute to development of the SOPs, work-instructions and other documentation.
  • Support individual and department development goals for larger business needs.
Required Skills

PhD, PharmD, MPharm, MSc, Mtech (BioMed or Bioinformatics) or equivalent.

Job Location
Base Branch: Baroda, Gujarat.
Remote work possible
Experience

At least 2 years of experience in medical writing or flair for writing with proven academic standards. Fair understanding of industry standards and global trends in drug and medical device domains. Highly proficient in MS Office and other software for authoring and data handling/interpretation.

Employment Type
Full-time
How to Apply

Email: hr@genproresearch.com

Subject:“Job Application: Sr Medical Writer & Evidence analyst”

Send your application to the above-mentioned email address with your resume in PDF format.

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Position: Sr Medical Writer & Evidence Analyst

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