Syneos Health invites application for the post of Medical Writer II (Narrative Writer) for Remote loaction.
About Syneos Health
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.
- Masters degree +2 year relevant narrative writing (safety) /Bachelors degree with 4 to 5 years of relevant NW experience
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
- 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:
- Clinical study protocols and clinical study protocol amendments;
- Clinical study reports;
- Patient narratives:
- 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.
- Minimal travel may be required (less than 25%).
India-Asia Pacific – IND-Home-Based