Senior Medical Writer
Company: Syneos Health
Location: India – Gurugram (Hybrid)
Experience Required: 3–5 years
Job Type: Medical Writing (Individual Contributor)
Job ID: 25108453
Role Overview
The Senior Medical Writer is responsible for developing high-quality clinical and regulatory documentation across the drug development lifecycle. The role involves writing, reviewing, and coordinating scientific documents used for regulatory submissions, clinical studies, and publications while ensuring compliance with global regulatory standards.
Key Responsibilities
Medical Writing & Documentation
Prepare and lead development of clinical and regulatory documents, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Investigator brochures
Informed consent forms (ICFs)
Annual reports and safety update reports (PSUR/DSUR)
Clinical development plans
IND/NDA/MAA/CTD submissions
Journal manuscripts, abstracts, posters, and scientific presentations
Plain language summaries and integrated summary reports
Scientific Review & Quality Control
Ensure clarity, consistency, and scientific accuracy of documents
Coordinate quality, editorial, and peer reviews
Review statistical analysis plans (SAPs) and TLF specifications
Ensure compliance with ICH E3, FDA guidelines, and internal SOPs
Perform literature searches and ensure proper citation practices
Cross-Functional Collaboration
Work closely with:
Clinical teams
Biostatistics
Data management
Regulatory affairs
Medical affairs
Resolve client comments and incorporate feedback into documents
Project & Stakeholder Management
Manage medical writing deliverables across studies
Coordinate timelines, budgets, and documentation workflows
Communicate with clients and internal stakeholders
Track project status and ensure on-time delivery
Mentorship & Process Improvement
Mentor junior medical writers
Provide technical guidance and training
Contribute to internal process improvements and best practices
Escalate and resolve documentation or project issues
Required Qualifications
Education
Bachelor’s or Master’s in Life Sciences, Pharmacy, Medicine, or related scientific field
Experience
3–5 years of medical writing experience in:
CRO, pharmaceutical, or medical device industry
Experience writing regulatory and clinical documents
Strong familiarity with:
FDA regulations
ICH guidelines (especially ICH E3)
Good Publication Practices (GPP)
AMA Manual of Style
Skills & Competencies
Strong scientific writing and editing skills
Excellent English grammar and communication ability
Ability to interpret clinical and statistical data
Strong attention to detail and consistency
Ability to manage multiple projects simultaneously
Strong collaboration and stakeholder management skills
Ability to work independently with minimal supervision
Additional Requirements
Ability to meet strict timelines and budget constraints
Exposure to end-to-end clinical development documentation
Optional travel (<25%)
Mentoring capability for junior writers
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Japan | Saitama |Tokyo :
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