Senior Medical Writer

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

📋 Description

• Oversee the precise and timely execution of medical writing deliverables.

• Manage medical writing tasks for individual studies and facilitate coordination across various departments.

• Lead the resolution of client feedback and comments.

• Produce clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations.

• Adhere to ICH E3 guidelines, organizational SOPs, client specifications, templates, authorship criteria, and style guides.

• Organize quality and editorial reviews and oversee source documentation management.

• Lead document reviews within the team and conduct peer evaluations.

• Review statistical analysis plans along with table, figure, and listing specifications.

• Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online searches of clinical literature and comply with copyright regulations.

• Identify and resolve issues, escalating as necessary.

• Provide technical assistance, training, and consultation.

• Contribute to the development of internal materials, presentations, processes, standards, and capabilities.

• Mentor and guide less experienced medical writers on intricate projects.

• Cultivate expertise in industry topics and regulatory requirements.

• Complete administrative responsibilities and other assigned tasks.

⛳️ Requirements

• At least 4 to 5 years of experience in medical writing.

• 3–5 years of relevant experience in scientific, technical, or medical writing.

• Experience in the biopharmaceutical, device, or contract research organization sectors.

• Familiarity with PK/PD studies, CSR, IB, ICF, and clinical protocols.

• Experience with Phase II/Phase III studies and readiness to work in Early Phase settings.

• Strong knowledge of FDA and ICH regulations, along with other regulatory guidelines and good publication practices.

• Proficient in writing various relevant document types.

• Extensive understanding of English grammar and the ability to communicate effectively.

• Well-versed in the AMA Manual of Style.

• Capability to operate within budgeted hours and provide updates and changes to medical writing leadership.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Minimal travel may be required (less than 25%).