Regulatory Medical Writer

5 days ago

Tumakuru, India JSS Medical Research Full time

Company Description JSS Medical Research is a full-service clinical research organization (CRO) with extensive operations across the globe. The organization has a strong reputation for its methodological expertise in designing and conducting clinical studies for all phases of development, including Phase I, II, III, and post-approval studies. JSS Medical Research is committed to partnering with clients throughout the entire product lifecycle to ensure successful outcomes. The organization is also recognized for its strong academic affiliations and continuous contributions to the industry through publications, webinars, and thought leadership. Role Description This is a full-time remote role for a Regulatory Medical Writer. The Regulatory Medical Writer will be responsible for drafting, reviewing, and finalizing regulatory documents such as clinical study reports, investigator brochures, and other essential documents. Responsibilities include performing literature reviews, adhering to regulatory guidelines, collaborating with cross-functional teams, and ensuring the accuracy and quality of scientific communication. The ideal candidate will work closely with stakeholders to meet project deadlines and regulatory compliance standards. Qualifications - Proficiency in medical and scientific writing, familiarity with regulatory document preparation, and the ability to interpret clinical and scientific data. - Strong understanding of clinical study designs, statistical principles, and regulatory guidelines such as ICH-GCP and FDA/EMA standards. - Excellent organizational skills, attention to detail, and the ability to meet tight deadlines. - Strong collaboration and communication skills with experience working in cross-functional teams. - Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant tools. - Advanced degree in life sciences, pharmacy, or a related scientific field; PhD or equivalent is considered an asset. - Previous experience in a similar role in the pharmaceutical, biotechnology, or clinical research industry is highly desirable.

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