Syneos Health Hiring Medical Writer I
- 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;
- Patient narratives;
- Investigator brochures.
- 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.
- 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 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%).
What we’re looking for
- MPharm qualification with relevant writing experience with relevant scientific and/or medical knowledge and expertise.
- Must have experience in Medical writing/ Regulatory Writing/ CTD domain
- 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.