Medical Writer- Future Roles (India)

Syneos Health, Inc.

Job Overview

Location

IND-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately, with minimal supervision.
• Manages medical writing activities for individual studies, coordinating across departments and teams to ensure timely and compliant delivery of documents.
• Prepares a wide range of regulatory and scientific documents including clinical study protocols and amendments, clinical study reports, patient narratives, investigator brochures, informed consents, annual reports, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts/posters/presentations for scientific meetings.
• Adheres strictly to regulatory standards including ICH E3 guidelines, company standard operating procedures, client-specific requirements, and approved templates, authorship rules, and style guides.
• Coordinates quality and editorial reviews, ensuring source documentation is properly managed and document integrity is maintained throughout the writing process.
• Acts as a peer reviewer for internal team members, evaluating scientific content, clarity, consistency, and formatting of medical documents.
• Reviews statistical analysis plans and table/figure/listing specifications for accuracy, grammar, format, and consistency, providing feedback to refine statistical output and document requirements.
• Builds and maintains strong working relationships with clients, department heads, and cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs.
• Conducts online clinical literature searches and ensures compliance with copyright requirements.
• Identifies and proposes solutions to resolve project issues, escalating concerns as appropriate to leadership.
• Provides technical support, training, and consultation to department staff and other company personnel.
• Mentors and guides less experienced medical writers on complex projects and document types.
• Develops deep expertise in key therapeutic areas, regulatory requirements, and industry guidelines affecting medical writing.
• Monitors project budgets, works within allocated hours, and communicates status updates and variances to medical writing leadership.
• Completes all required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned, with minimal travel required (less than 25%).

🎯 Requirements

• 3-5 years of relevant experience in science, technical, or medical writing
• Experience working in the biopharmaceutical, device, or contract research organization industry
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
• Experience writing relevant document types such as clinical study protocols, clinical study reports, IND/NDA submissions, and journal manuscripts
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

🏖️ Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Commitment to a Total Self culture promoting authenticity and belonging
• Diversity of thoughts, backgrounds, cultures, and perspectives valued in the workplace

Skills & Technologies

Remote

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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