Principal Medical Writer

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

📋 Description

• Deliver high-quality medical and scientific writing, overseeing the process from planning and coordination to the completion of final drafts for both internal and external clients.

• Act as the lead writer, reviewing documents created by the team and offering training and guidance to less experienced team members.

• Provide expert advice on document development strategies, regulations, and best practices within the industry.

• Work collaboratively with both internal and external clients to foster effective and efficient communication.

• Conduct research, write, and edit clinical study reports and study protocols.

• Summarize clinical study data effectively.

• Take on the role of primary author for intricate clinical, scientific, and program-level documents, including Investigator's Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).

• Conduct senior-level reviews of both routine and complex documents.

• Ensure adherence to quality processes and compliance with established requirements.

• Formulate and review best practices while leading initiatives aimed at process improvement.

• Develop, review, and manage performance metrics associated with assigned projects.

• Act as a backup program manager and address any out-of-scope activities.

• Represent the department during project launches, reviews, and team meetings.

⛳️ Requirements

• Exhibits expertise in subject matter and therapeutic areas.

• Proven experience in researching, writing, and editing clinical study reports and study protocols.

• Capable of summarizing data derived from clinical studies.

• Proficient in authoring complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs.

• Skilled in providing senior-level reviews of both routine and complex documents.

• Capable of training and mentoring writers and program managers on document preparation, document development software, document types, regulatory requirements, and therapeutic area knowledge.

• Well-versed in quality processes and compliance requirements.

• Ability to develop and review best practices, methods, and techniques.

• Competent in managing performance metrics for assigned projects.

• Available to serve as a backup program manager.

• Skilled in developing timelines, budgets, forecasts, and contract modifications.

• Able to assist with client presentations, proposal text reviews, bid defense meetings, and capabilities presentations.

• Full-time availability on a standard Monday to Friday schedule.

🏝️ Benefits

• Competitive salary and comprehensive health benefits.

• Opportunities for professional development and career advancement.

• A collaborative and supportive work environment.