Job Title:
Medical Writer I (CTD/CTT)
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By combining clinical, medical affairs, and commercial insights, we deliver outcomes that address modern market needs.
With 29,000 employees across 110 countries, our mission is to keep both the customer and the patient at the center of everything we do. We continuously strive to simplify processes, drive innovation, and accelerate the delivery of therapies that change lives.
Work Here Matters Everywhere.
Why Syneos Health?
Career development and progression opportunities
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
A Total Self culture that fosters authenticity and belonging
A diverse, inclusive, and collaborative workplace where everyone feels valued
Position Summary
The Medical Writer I serves as a key member of clinical study and regulatory project teams. This role involves writing, editing, and coordinating content for a wide range of clinical and regulatory documents, ensuring quality, compliance, and timely delivery.
Key Responsibilities
Act as a medical writer for clinical trial disclosure (CTD/CTT) deliverables with 6 months–1 year of experience in the field.
Support and prepare documentation for:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Investigator brochures (IBs)
Patient narratives
Perform protocol registration and results registration for clinical trials.
Review statistical analysis plans, tables, figures, and listings for accuracy, clarity, format, and consistency.
Collaborate with cross-functional teams (Data Management, Biostatistics, Regulatory Affairs, Medical Affairs).
Adhere to regulatory standards (ICH-E3, SOPs, client guidelines, templates).
Conduct online clinical literature searches as needed.
Maintain awareness of project budgets, timelines, and communicate risks or changes.
Ensure professional development to keep current with evolving regulatory guidance.
Complete administrative tasks within defined timelines.
Perform other assigned duties; minimal travel (<25%) may be required.
Qualifications
Minimum 6 months–1 year experience in clinical trial disclosure/CTT.
Strong experience in protocol and results registration.
Excellent communication and client management skills.
Working knowledge of regulatory guidelines (ICH-E3) and medical writing best practices.
Ability to collaborate effectively across departments.
Detail-oriented, organized, and able to meet deadlines within budget.
Additional Information
Responsibilities listed are not exhaustive; additional tasks may be assigned.
Equivalent experience, education, or transferable skills will be considered.
Syneos Health complies with global employment legislation, including ADA accommodations and EU Equality Directive requirements.
No employment contract is created by this description.
About Syneos Health’s Impact
Partnered with 94% of all novel FDA-approved drugs in the last 5 years
Supported 95% of EMA-authorized products
Conducted 200+ studies across 73,000 sites with 675,000+ trial patients
Application Process
Interested candidates are encouraged to apply. If your experience does not align perfectly, we still welcome your application and invite you to join our Talent Network to stay connected to future opportunities.
[Apply Now] | [Join Talent Network]
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