Principal Medical Writer ( Regulatory Medical Writing docs)

Syneos Health; India; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Syneos Health, Inc. is seeking a Principal Medical Writer to lead regulatory medical writing across protocols, CSRs, PSURs, DSURs and related documents. The role emphasizes end-to-end document development in a CRO setting and close collaboration with pharmaceutical clients.

The successful candidate will mentor junior writers, drive high-quality submissions on time and within budget, and advise study teams on data presentation and editorial strategy in line with ICH guidelines.

Qualifications

• 5+ years of Regulatory Medical Writing experience with expertise in authoring Protocols, Protocol Amendments, CSRs, Narratives, PSURs, DSURs, ICFs, and IBs.

Responsibilities

• Leads the clear and accurate completion of complex medical writing deliverables, coordinating with departments with minimal supervision.
• Completes documents that may include clinical study protocols and protocol 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.
• Adheres to established regulatory standards, including ICH E3 guidelines, SOPs, client standards, and templates, ensuring on-time, on-budget delivery.
• Advises clients and study teams on data presentation and production strategies to meet client objectives and maintain quality.
• Leads team document reviews and coordinates quality/editorial reviews, ensuring source documentation is managed.
• Serves as expert peer reviewer for internal team, providing comments to improve clarity, accuracy, and relevance.
• Reviews statistical analysis plans and tables/figures/listings for content, grammar, and consistency.
• Interacts with clients, department heads, and team members across data management, biostatistics, regulatory, and medical affairs to deliver writing.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key industry topics and regulatory guidelines.

Skills

Regulatory medical writing

Lead medical writer

Mentoring

Client collaboration

Document development

Job description

Principal Medical Writer ( Regulatory Medical Writing docs)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

5+ years of Regulatory Medical Writing experience with expertise in authoring Protocols, Protocol Amendments, CSRs, Narratives, PSURs, DSURs, ICFs, and IBs.

Proven Lead Medical Writer experience, independently managing end-to-end document development in a CRO environment while partnering with pharmaceutical companies.

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; 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, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
• Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Works with staff across company to advance company priorities.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Contributes to changes to internal process, standard practices, and capabilities.
• Mentors and leads less experienced medical writers on complex documents.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect med