Medical Writer Ii (Clinical Trial Transparency)

Syneos Health

1-3 years

preferred by company

India Pune

10 Jan. 20, 2026

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Writer II – Clinical Trial Transparency (Disclosure)

Location: Pune, Maharashtra, India
Job ID: 25101809
Category: Medical Writing | Clinical Trial Transparency | Regulatory Disclosure
Experience Required: 1–3 Years
Updated On: January 5, 2026
Employment Type: Full-Time

Job Overview

Syneos Health®, a global biopharmaceutical solutions organization, is seeking a skilled Medical Writer II – Clinical Trial Transparency to support global clinical trial disclosure and regulatory transparency activities. This role is critical in ensuring compliance with international clinical trial registries, regulatory requirements, and disclosure timelines across multiple geographies.

The position is well-suited for medical writers with hands-on experience in clinical trial disclosure, registry submissions, and transparency regulations, who are eager to contribute to high-impact global clinical development programs.

Key Responsibilities

Clinical Trial Transparency & Disclosure

Execute end-to-end clinical trial disclosure activities in compliance with global regulations.
Prepare, review, and submit clinical trial data to global registries including ClinicalTrials.gov, CTIS (Clinical Trial Information System), and EudraCT.
Manage protocol registration, results disclosure, and ongoing maintenance of registry records.
Perform disclosure activities using industry-standard tools and databases such as PharmaCM and Disclose.
Support disclosure projects involving document redaction and transparency compliance.

Medical Writing & Documentation

Compile, write, edit, and review a range of medical writing deliverables with minimal supervision.
Develop and support regulatory and clinical documents, including:
- Clinical study protocols and protocol amendments
- Clinical Study Reports (CSRs)
- Patient narratives
- Annual safety reports
- Investigator Brochures
Ensure accuracy, clarity, consistency, and scientific integrity across all documents.

Cross-Functional Collaboration

Collaborate with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs teams to deliver high-quality documentation.
Serve as a peer reviewer, addressing review comments effectively to meet regulatory and client expectations.
Mentor and support junior medical writers as required.

Compliance & Quality

Ensure adherence to ICH-E3 guidelines, FDA and global regulatory standards, company SOPs, client standards, and approved templates.
Review statistical analysis plans (SAPs) and tables, figures, and listings (TFLs) for accuracy and alignment with clinical data.
Conduct online literature searches to support document development.
Maintain inspection readiness through compliant documentation practices.

Project & Professional Management

Work within allocated project budgets and timelines, proactively communicating risks or changes.
Stay current with evolving regulatory guidance, disclosure requirements, and industry best practices.
Complete administrative and project-related tasks within defined timelines.
Perform additional responsibilities as assigned based on project needs.

Required Qualifications

Bachelor’s degree in a relevant scientific or life sciences discipline.
Graduate degree (Master’s or PhD) is preferred.
Proven client-facing experience in medical writing or disclosure activities.
Strong understanding of FDA, ICH, EMA regulations, and clinical trial transparency requirements.
Demonstrated experience authoring relevant medical writing and disclosure documents.
Excellent command of written English with strong knowledge of the AMA Manual of Style.

Experience Required

1 to 3 years of professional experience in clinical trial disclosure or clinical trial transparency.
Mandatory experience with clinical trial registries such as ClinicalTrials.gov, CTIS, and EudraCT.
Hands-on experience with disclosure databases/tools (e.g., PharmaCM, Disclose).
Working knowledge of the drug development lifecycle and regulatory submission processes.

Required Skills & Competencies

Strong medical writing, editing, and proofreading skills.
Excellent understanding of clinical research principles and medical terminology.
Ability to interpret, analyze, and present complex clinical data clearly.
Strong project management, organizational, and time-management skills.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
Effective communication, collaboration, and stakeholder management skills.

Travel Requirements

Minimal travel may be required (less than 25%).

About Syneos Health

Syneos Health® is a leading global biopharmaceutical solutions organization with operations across 110 countries. Over the past five years, Syneos Health has supported 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and more than 200 studies across 73,000 sites and 675,000+ trial participants worldwide.

At Syneos Health, employees are empowered to challenge the status quo, collaborate across functions, and contribute to meaningful advancements in healthcare and clinical research.

Equal Opportunity Statement

Syneos Health is committed to providing equal employment opportunities and maintaining an inclusive work environment. Reasonable accommodations are available throughout the recruitment process in accordance with applicable laws and regulations.

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Medical Writer Ii (Clinical Trial Transparency)

Job Description

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