Medical Writer

17 hours ago

Pune, Maharashtra, India Syneos Health Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Role & responsibilities:


•    Mentors less experienced medical writers on projects, as necessary.

•    Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. 

•    Develops or supports a variety of documents that include but not limited to: 

     o    Clinical study protocols and clinical study protocol amendments;

     o    Clinical study reports;

     o    Patient narratives;

     o    Annual reports;

     o    Investigator brochures.

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

•    Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. 

•    Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.

•    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. 

•    Working knowledge of drug development process and regulatory guidelines.

•    Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.

•    Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

•    Completes required administrated tasks within the specified timeframes.

•    Performs other work-related duties as assigned.

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