Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Post : Medical Writer I (CSR Narrative)
Job Description
• Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
• Develops or supports, a variety of documents that include but not limited to:
• Clinical study protocols and clinical study protocol amendments;
• Clinical study reports;
o Patient narratives;
o Investigator brochures.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and co sistency. Provides feedback to further define statistical output required.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• 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 when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
• Is aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to med cal writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
Candidate Profile
• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar with a familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines strongly preferred.
• Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Additional Information
Experience : Min 1yr
Qualification : Bachelor of Science degree
Location : Hyderabad, Gurugram
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CSR Narrative
End Date : 30th November 2026
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