Medical Writer- Future Roles (India)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do.

About the role

Roles within the Medical Writing job family are responsible for writing and editing manuscripts and other medical communications on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. Conducts systematic literature searches and reviews. Prepares literature for new products and revises existing medical communication. Reviews and analyzes statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, 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; 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.
• Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• 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 relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate.
• Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be 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 required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

About 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.