Medical Writer II
Location: IND-Remote
Updated: August 29, 2025
Job ID: 25101318
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes.
Patient- and customer-centric Clinical Development model
Agile, collaborative, and innovative teams
29,000 employees across 110 countries
Global Impact:
94% of novel FDA-approved drugs and 95% of EMA-authorized products in the last 5 years
200+ studies across 73,000 sites and 675,000+ trial patients
Learn more: www.syneoshealth.com
Why Syneos Health
Career Development: Training, mentorship, and progression opportunities
Inclusive Culture: Total Self culture fostering authenticity and belonging
Collaboration: Cross-functional teamwork to achieve customer goals
Role Summary
The Medical Writer II leads medical writing activities for clinical and regulatory documents, ensuring scientific information is accurate and clearly presented.
Focus on clinical trial disclosure, registries, and regulatory submissions
1–3 years of relevant experience in clinical trial disclosure required
May involve combination of redaction and disclosure activities
Core Responsibilities
Medical Writing & Document Support
Complete documents including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Annual reports, investigator brochures, informed consents
Plain language summaries, periodic safety update reports
Clinical development plans, IND submissions, integrated summary reports, NDA/eCTD submissions
Journal manuscripts, abstracts, posters, and scientific presentations
Ensure deliverables comply with regulatory standards (ICH E3, company SOPs, client standards, approved templates)
Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
Perform online clinical literature searches and maintain copyright compliance
Collaboration & Leadership
Coordinate medical writing activities across departments with minimal supervision
Interact with clients, department heads, and peers in:
Data Management, Biostatistics, Regulatory Affairs, Medical Affairs
Act as a peer reviewer for internal team members
Mentor and guide less experienced medical writers on complex projects
Compliance & Process
Adhere to established regulatory standards and internal SOPs
Ensure source documentation is managed appropriately
Maintain awareness of project budgets and complete work within allocated hours
Identify and propose solutions to resolve issues, provide technical support and training
Qualifications & Experience
1–3 years of experience in clinical trial disclosure
Knowledge of clinical research, clinical trials, and clinical registries (CT.gov, CTIS, EUDRACT)
Bachelor’s degree in a relevant discipline (graduate degree preferred)
Client interaction experience preferred
Key Skills
Strong presentation, proofreading, collaborative, and interpersonal skills
Strong project and time management skills
Proficiency in MS Office
Strong understanding of medical terminology, clinical research principles, and data interpretation
Additional Information
Tasks and responsibilities may be adjusted at company discretion
Equivalent skills and experience will be considered
Compliance with employment legislation and ADA requirements
How to Apply
Apply via Syneos Health careers portal
Join the Talent Network to stay connected with future opportunities
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