Senior Medical Writer
Company: Syneos Health
Location: IND – Remote
Job ID: 25108453
Experience Level: 3–5 years
Updated On: May 8, 2026
Company Overview
Syneos Health is a global life sciences services organization that supports drug development and commercialization across the full clinical and regulatory lifecycle. It works with pharmaceutical and biotech companies to deliver clinical, regulatory, and medical communication solutions.
Role Summary
The Senior Medical Writer is responsible for:
Leading preparation of clinical and regulatory medical writing deliverables
Ensuring scientific accuracy, clarity, and regulatory compliance
Managing medical writing activities across clinical studies
Coordinating cross-functional input and client communication
Key Responsibilities
1. Medical Writing Deliverables
Develop and finalize high-quality documents, including:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Investigator Brochures
Informed Consent Forms
Patient Narratives
Regulatory submission documents (IND, NDA, eCTD)
Safety reports (e.g., PSURs)
Publications (manuscripts, abstracts, posters)
Ensure clarity, accuracy, and scientific consistency
2. Regulatory Compliance
Follow ICH guidelines (e.g., ICH E3)
Adhere to FDA, EMA, and global regulatory standards
Ensure compliance with company SOPs, templates, and formatting standards
3. Review & Quality Control
Coordinate editorial and quality reviews
Review statistical outputs (SAPs, TLF specifications)
Ensure consistency in grammar, formatting, and scientific content
Serve as peer reviewer for internal documents
4. Cross-Functional Collaboration
Work closely with:
Biostatistics teams
Data management teams
Regulatory affairs teams
Medical affairs teams
Incorporate feedback into final deliverables
Manage client interactions and resolve comments
5. Project & Document Management
Manage medical writing deliverables across studies
Ensure on-time and on-budget delivery
Track document progress and resolve issues proactively
Maintain source documentation and literature references
6. Literature & Scientific Research
Conduct systematic literature searches
Summarize scientific data from multiple sources
Ensure compliance with copyright and publication ethics
7. Mentoring & Leadership
Mentor junior medical writers
Provide training and technical guidance
Support process improvements and internal documentation development
8. Budget & Timeline Management
Work within allocated project budgets
Track writing hours and project progress
Communicate status updates to leadership
Required Skills & Experience
3–5 years of medical/scientific writing experience
Experience in biopharmaceutical, CRO, or device industry
Strong knowledge of:
FDA regulations
ICH guidelines
Good publication practices
Strong English writing and communication skills
Familiarity with AMA Manual of Style
Experience writing regulatory and clinical documents
Preferred Competencies
Experience with global clinical trials and submissions
Strong scientific interpretation skills
Ability to manage multiple writing projects
Exposure to regulatory agency interactions
Leadership or mentoring experience
Work Environment
Remote (India-based)
Global clinical and regulatory communication teams
High-volume regulatory writing environment
Close collaboration with cross-functional scientific teams
Role Impact
Ensures high-quality regulatory submissions and clinical documentation
Supports approvals of new therapies through accurate documentation
Bridges scientific data with regulatory requirements
Improves clarity and consistency in global clinical communication
Career Progression
This role can lead to:
Senior / Principal Medical Writer
Regulatory Writing Lead
Medical Communications Manager
Clinical Development Documentation Lead
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