Principal Medical Writer

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%).

Qualifications

• 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.