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.
Roles And Responsibilities
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.
- Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
- Develops good working relationships with internal and external colleagues.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities 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 protocol amendments;
o Clinical study reports;
o Patient narratives;
o Clinical development plans;
o IND submissions and annual reports;
o Integrated summary reports;
o NDA and (e)CTD submissions;
o Investigator brochures, as well as;
o Clinical journal manuscripts, clinical journal abstracts, and client presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
- Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
- Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, 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.
- Understands 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%).
- 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.