Job Description

Medical Writing


Posted on Apr 17, 2024


Remote-India
Minimum Required Experience : 3 years


Full Time


Skills


Medical Writing
Description





Job summary:

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 & review 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



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


Experience:


At least 3 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.


Work Location : Base Branch: Baroda, Gujarat. Remote / Work from home possible after initial induction for a deserving candidate with a proven track record.