Senior Medical Writer (Authoring CSR Narratives)
Company: Syneos Health
Updated: April 28, 2025
Location: IND-Home-Based
Job ID: 25002558
About Syneos Health:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success through integrated clinical, medical affairs, and commercial solutions. With over 29,000 employees across 110 countries, we are driven by passion, purpose, and the desire to make a difference.
Why Join Us:
Focus on people development through training, mentoring, and career growth opportunities
Total Self culture: Be your authentic self in a diverse, inclusive environment
Global impact: Support groundbreaking therapies with a collaborative, innovative team
Recognized performance: 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products supported over the last 5 years
Job Responsibilities:
Mentor and lead less experienced writers on complex projects as needed
Act as the lead writer for assigned projects, independently managing writing activities
Develop a range of regulatory and clinical documents, including but not limited to:
Clinical study protocols/amendments
Clinical study reports (CSRs)
Patient narratives
Clinical development plans
IND submissions and annual reports
Integrated summary reports
NDA and (e)CTD submissions
Investigator brochures
Manuscripts, abstracts, client presentations
Identify and resolve issues arising during writing processes
Review statistical plans and outputs for accuracy and consistency
Collaborate with cross-functional teams (data management, regulatory, biostatistics, etc.)
Serve as peer reviewer to ensure high editorial standards
Ensure compliance with ICH-E3, SOPs, client standards, and templates
Conduct clinical literature searches
Monitor timelines and budgets; report variances to leadership
Complete administrative tasks and support additional responsibilities as assigned
Travel requirement: Less than 25%
Qualifications:
Bachelor of Science degree with relevant writing experience, or
Bachelor of Arts in Social Sciences, English, or Communications with medical/scientific expertise
In-depth knowledge of English grammar, FDA/ICH guidelines, and AMA style
Proven independence in managing projects and teams
Strong proficiency in MS Office and Internet tools
Ability to interpret and present clinical data accurately
Additional Information:
All duties and responsibilities are subject to change without prior notice. Equivalent experience and skills will be considered. Syneos Health is committed to providing equal opportunities and accommodations in compliance with applicable laws, including the Americans with Disabilities Act.
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