Senior Medical Writer

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

📋 Description

• Oversees the precise and thorough completion of medical writing deliverables, ensuring that scientific information is conveyed clearly and accurately.

• Manages medical writing tasks related to individual studies, coordinating activities across departments with minimal supervision.

• Facilitates the resolution of client comments.

• Produces a diverse range of documents which may include clinical study protocols and amendments; clinical study 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; and abstracts, posters, and presentations for scientific conferences.

• Complies with established regulatory standards, including but not limited to ICH E3 guidelines, as well as company SOPs, client standards, and approved templates, authorship requirements, and style and formatting guides, ensuring timely and budget-conscious completion of medical writing projects.

• Coordinates quality assurance and editorial reviews.

• Ensures proper management of source documentation.

• Leads document reviews within the team and evaluates documents as necessary.

• Serves as a peer reviewer for the internal team to verify the scientific content, clarity, overall consistency, and correct formatting of documents.

• Assesses statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.

• Provides feedback to clarify statistical outputs and document requirements.

• Engages and fosters positive working relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as required to deliver writing outputs.

• Conducts online clinical literature searches and adheres to copyright regulations.

• Identifies and suggests solutions to challenges, escalating issues when necessary.

• Offers technical support, training, and consultation to departmental and other company personnel.

• May assist in the development of internal materials and presentations or in modifications to internal processes, standard practices, and capabilities.

• Mentors and guides less experienced medical writers on complex projects as needed.

• Cultivates in-depth knowledge on key industry topics and the regulatory requirements and guidelines influencing medical writing.

• Maintains awareness of budget guidelines for assigned projects, ensuring work is completed within the allocated hours and communicating status and changes to medical writing leadership.

• Completes necessary administrative tasks within designated timeframes.

• Undertakes other work-related duties as assigned.

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

⛳️ Requirements

• 3-5 years of pertinent experience in scientific, technical, or medical writing.

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

• A strong understanding of FDA and ICH regulations, as well as other regulatory guidelines and good publication practices, is essential.

• Proven experience in writing relevant document types is required.

• Comprehensive knowledge of English grammar and clear communication skills; strong familiarity with the AMA Manual of Style is necessary.

🏝️ Benefits

• We are dedicated to developing our people through career advancement and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and total rewards program.

• We are committed to fostering an inclusive culture where you can authentically be yourself.