Location: India – Remote
Job ID: 25101318
Updated: August 29, 2025
Company: Syneos Health®
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by converting clinical, medical affairs, and commercial insights into impactful outcomes. With a global workforce of over 29,000 employees across 110 countries, we prioritize patients and customers in everything we do.
Our Impact:
Supported 94% of novel FDA-approved drugs in the last 5 years
Assisted with 95% of EMA-authorized products
Managed 200+ studies across 73,000+ sites and 675,000+ trial patients
The Medical Writer II will lead and manage medical writing activities related to clinical trial disclosure and regulatory documentation. The role requires 1 to 3 years of disclosure experience, familiarity with clinical registries, and the ability to handle multiple types of medical writing deliverables with minimal supervision.
Lead the clear and accurate creation of various medical writing deliverables, including but not limited to:
Clinical study protocols, amendments, and reports
Patient narratives
Annual reports
Investigator brochures
Informed consent forms
Plain language summaries
Periodic safety update reports
Clinical development plans
IND submissions
Integrated summary reports
NDA and eCTD submissions
Journal manuscripts, abstracts, posters, and scientific presentations
Manage and contribute to clinical trial registries including ClinicalTrials.gov, CTIS (Clinical Trial Information System), and EUDRACT.
Ensure accurate registration and disclosure compliance.
Experience with redaction and disclosure combinations is welcomed.
Coordinate quality and editorial reviews, managing source documentation properly.
Act as a peer reviewer to ensure scientific content accuracy, clarity, consistency, and formatting.
Review Statistical Analysis Plans and TFL (Tables, Figures, Listings) specifications, providing constructive feedback.
Build and maintain effective relationships with clients, department heads, and peers in Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
Mentor and guide junior medical writers on complex projects.
Identify and propose solutions to technical or process issues.
Provide training and consultation support across the department.
Stay current with regulatory guidelines including FDA, ICH E3, and publication practices.
Perform clinical literature searches and comply with copyright regulations.
Work within project budget specifications and communicate deviations proactively.
| Requirement | Details |
|---|---|
| Experience | 1 to 3 years in clinical trial disclosure or medical writing |
| Education | Bachelor’s degree in a relevant discipline required; graduate degree preferred |
| Technical Knowledge | Strong knowledge of clinical research, clinical trial registries (ClinicalTrials.gov, CTIS, EUDRACT), FDA/ICH regulations, and publication practices |
| Writing Skills | Extensive experience writing clinical and regulatory documents; familiarity with AMA Manual of Style |
| Client Interaction | Proven experience in client communication and management |
| Tools & Skills | Proficiency in MS Office; excellent proofreading, presentation, collaboration, and interpersonal skills |
| Medical Knowledge | Strong understanding of medical terminology, clinical research principles, and data interpretation |
Supportive career development and progression opportunities
Inclusive, diverse, and authentic Total Self culture
Access to technical and therapeutic area training, peer recognition, and total rewards
Opportunity to work in a globally connected and agile team focused on making a difference in patients’ lives
Job responsibilities may evolve based on business needs.
Equivalent experience, skills, and education may be considered.
Syneos Health is an Equal Opportunity Employer and complies with the Americans with Disabilities Act (ADA) and relevant employment legislation globally.
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“We encourage applicants with diverse backgrounds and transferable skills to apply, even if all qualifications are not met perfectly.”
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