Medical Writer II – Clinical Trial Transparency
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25101809
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a globally integrated biopharmaceutical solutions organization focused on accelerating customer success across clinical development, medical affairs, and commercial operations. With a strong patient-centric approach, Syneos Health partners with sponsors worldwide to navigate regulatory complexity and deliver high-quality clinical and scientific outcomes.
With over 29,000 employees across 110+ countries, Syneos Health has supported the majority of recent FDA and EMA approvals, making it a leader in clinical research transparency and regulatory compliance.
Role Overview
The Medical Writer II – Clinical Trial Transparency is responsible for preparing, reviewing, and managing disclosure-related medical writing deliverables in compliance with global clinical trial transparency regulations. This role focuses on clinical trial disclosure, registry submissions, and transparency documentation, ensuring accuracy, regulatory compliance, and timely publication across global registries.
Key Responsibilities
Clinical Trial Disclosure and Transparency
Support clinical trial disclosure activities in accordance with global transparency regulations.
Prepare, review, and maintain submissions for clinical trial registries, including but not limited to:
ClinicalTrials.gov (CT.gov)
CTIS (Clinical Trial Information System)
EudraCT
Manage disclosure activities using industry-standard systems such as Pharma CM, Disclose, or similar platforms.
Support protocol registration, results disclosure, and redaction activities, including combined redaction and disclosure workflows where applicable.
Medical Writing and Documentation
Compile, write, and edit medical writing deliverables with minimal supervision, including:
Clinical study protocols and protocol amendments
Clinical study reports (CSRs)
Patient narratives
Annual reports
Investigator brochures (IBs)
Review statistical analysis plans (SAPs) and table, figure, and listing (TFL) specifications for content accuracy, clarity, format, and consistency.
Ensure all documents comply with ICH-E3, FDA, EMA, and other applicable regulatory guidelines, as well as internal SOPs, client standards, and approved templates.
Cross-Functional Collaboration and Quality
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams to deliver high-quality writing outputs.
Serve as a peer reviewer, addressing review comments to ensure scientific accuracy, clarity, consistency, and regulatory compliance.
Conduct online clinical literature searches as required to support writing deliverables.
Mentor and support less experienced medical writers when assigned.
Operational Excellence
Maintain awareness of project budgets and timelines, working within allocated hours and proactively communicating risks or changes.
Complete required administrative and compliance-related tasks within defined timelines.
Continue professional development to stay current with evolving regulatory guidance and best practices in clinical trial transparency and medical writing.
Perform additional duties as assigned.
Minimal travel may be required (less than 25%).
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline with relevant medical writing experience.
A graduate degree (Master’s or PhD) is preferred.
Experience
1–3 years of hands-on experience in clinical trial disclosure and transparency.
Mandatory experience with clinical trial registries such as CT.gov, CTIS, and/or EudraCT.
Proven experience in clinical trial disclosure databases (e.g., Pharma CM, Disclose, or equivalent).
Client-facing experience is required.
Required Skills and Competencies
Strong understanding of FDA, EMA, ICH regulations, and global clinical trial transparency requirements.
Solid knowledge of the drug development lifecycle and clinical research processes.
Excellent command of English grammar and scientific writing, with strong familiarity with the AMA Manual of Style.
Strong proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
Excellent proofreading, presentation, collaboration, and interpersonal skills.
Strong project management and time management capabilities.
Ability to interpret and clearly present complex clinical and scientific data.
Why Join Syneos Health
Work on disclosure activities supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Be part of a globally recognized organization committed to transparency, quality, and patient safety.
Access structured career development, technical training, and a collaborative global work environment.
Equal Opportunity Statement
Syneos Health is an equal opportunity employer and complies with all applicable employment laws and regulations, including providing reasonable accommodations for qualified individuals with disabilities.
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