Senior Medical Writer

This is a fully remote position, open to applicants in India.

📋 Description

• Create and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.

• Execute literature reviews and assess scientific and clinical data to aid in document creation.

• Ensure that documents adhere to ICH-GCP, FDA, EMA, client specifications, SOPs, and regulatory standards.

• Facilitate cross-functional reviews, manage document timelines, and integrate feedback from stakeholders.

• Act as the Medical Writing representative on project teams and serve as the main point of contact for assigned projects.

• Review statistical outputs to guarantee accurate presentation and interpretation of clinical data.

• Conduct quality reviews to ensure data consistency, accuracy, and readiness for publication.

• Guide junior writers and engage in process enhancement, training, and SOP development initiatives.

⛳️ Requirements

• A Bachelor's, Master's, PharmD, MD, PhD, or an equivalent degree in Life Sciences, Pharmacy, Medicine, or a related discipline.

• Experience in Medical Writing is essential, ideally within a CRO, pharmaceutical, or biotechnology setting.

• Extensive experience in authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents.

• Strong knowledge of clinical research, drug development processes, and ICH-GCP guidelines.

• Exceptional scientific writing, editing, and communication abilities.

• Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.

🏝️ Benefits

• Health insurance

• Professional development opportunities