Description
Syneos Health is seeking a Medical Writer I (CTT) to join their team. The successful candidate will serve as a medical writer on clinical study or regulatory project teams, assisting in writing, editing, and coordinating content for clinical/regulatory documents.
Job Responsibilities
- Compiles, writes, and edits medical writing deliverables, serving as a medical writer within and across departments with moderate supervision.
- Develops or supports various documents, including:
- Clinical study protocols and amendments
- Clinical study reports
- Patient narratives
- Investigator brochures
- Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Interacts with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
- Adheres to established regulatory standards, including ICH-E3 guidelines and Company Standard Operating Procedures.
- Performs online clinical literature searches as applicable.
- Continues professional development to keep pace with regulatory guidance and client expectations.
- Is aware of budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
- Completes required administrative tasks within specified timeframes.
- Performs other work-related duties as assigned, with minimal travel (less than 25%).
Requirements
- Minimum 1 year of experience in clinical trial disclosure or CTT.
- Good experience in protocol registration and result registration.
- Experience with results posting for regulatory bodies.
What We Offer
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture, allowing you to authentically be yourself