Job Title:
Medical Writer II
Company:
Syneos Health®
Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company merges clinical, medical affairs, and commercial insights to deliver innovative solutions. With over 29,000 employees across 110 countries, Syneos Health is committed to driving biopharmaceutical innovation and improving patient outcomes.
Why Syneos Health:
Career development and progression support
Supportive and engaged management
Technical and therapeutic area training
Peer recognition and total rewards programs
"Total Self" culture for authentic self-expression
Diverse and inclusive workplace environment
Job Responsibilities:
Mentor less experienced medical writers
Compile, write, and edit medical writing deliverables
Independently develop or support various documents including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Annual reports
Investigator brochures
Review statistical analysis plans and TFL specs
Collaborate across departments (data management, biostats, regulatory, medical affairs)
Serve as a peer reviewer ensuring clarity, consistency, and scientific accuracy
Follow ICH-E3 guidelines, SOPs, and approved templates
Perform online clinical literature searches
Maintain working knowledge of drug development and regulatory guidelines
Monitor budget and hours for assigned projects
Complete administrative tasks within deadlines
Perform additional assigned duties
Minimal travel (<25%) may be required
Qualifications:
Bachelor of Science (with relevant writing experience)
OR
Bachelor of Arts (Social Sciences, English, Communications preferred) with relevant scientific/medical knowledge
Strong command of English grammar and familiarity with AMA style guide
Knowledge of FDA and ICH regulations
Proven independence and leadership skills
Effective presentation, proofreading, and interpersonal skills
Strong MS Office (Word, Excel, PowerPoint), email, and internet skills
Ability to interpret and present clinical data clearly
Additional Information:
The job description is not exhaustive
The company may assign additional responsibilities
Equivalent experience or education may be considered
Compliant with ADA and EU Equality Directive
Reasonable accommodations will be provided as needed
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