PHARMAFull-time
Medical Writer I / Medical Writer II (CSR Narratives)
By Admin · Medical & Scientific Writing
DELHI NCR (IN)HYBRIDPOSTED: 8/28/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Compile, write, and edit medical writing deliverables while working as a medical writer within and across departments with minimal supervision.
Mentor less experienced medical writers on projects when required.
Develop and support clinical and regulatory documents including clinical study protocols, protocol amendments, clinical study reports (CSRs), patient narratives, annual reports, and investigator brochures.
Review statistical analysis plans and table, figure, and listing specifications for content, grammar, formatting, and consistency.
Work with data management, biostatistics, regulatory affairs, medical affairs, department heads, and other stakeholders to produce accurate writing deliverables.
Serve as a peer reviewer and address review comments accurately to maintain scientific content, clarity, consistency, and appropriate formatting.
Conduct online clinical literature searches when applicable.
Complete medical writing projects according to established regulatory standards, company SOPs, client standards, and approved company/client templates, while meeting timelines and budgets.
Maintain awareness of project budgets, work within budgeted hours, and communicate changes to medical-writing leadership.
Complete required administrative activities within specified timeframes and perform additional assigned duties.
Minimal travel may be required, stated as less than 25%.
Regulatory & Scientific Standards
Apply ICH-E3 requirements and other applicable regulatory standards and guidelines to medical writing deliverables.
Maintain working knowledge of the drug-development process and regulatory guidelines.
Demonstrate knowledge of FDA and ICH regulations and guidelines.
Apply familiarity with the AMA style guide and strong English grammar principles.
Interpret and present clinical data and other complex clinical information accurately and clearly.
Qualifications & Experience
Minimum 1 year of experience working with clinical narratives for candidates with a Master's qualification.
Minimum 2 years of experience working with clinical narratives for candidates with a Bachelor's degree.
Master's/M.Pharm or Bachelor's degree accepted.
Demonstrated experience drafting and reviewing narratives is required.
Strong proficiency in Microsoft Word, Excel, PowerPoint, email, and Internet-based tools.
Strong independence, presentation, proofreading, interpersonal, leadership, and team-oriented capabilities are expected.
Collaboration & Business Impact
Collaborate across clinical, data-management, biostatistics, regulatory, and medical-affairs functions to produce high-quality clinical documentation.
Contribute to timely and compliant clinical-development deliverables supporting customers across the drug-development and commercialization continuum.
Maintain scientific accuracy, document consistency, regulatory compliance, and client expectations across assigned projects.
Continue professional development to remain current with regulatory guidance, medical-writing practices, and evolving client expectations.
Company & Career Environment
Syneos Health describes itself as a fully integrated life-sciences services organization supporting customers throughout drug development and commercialization.
The Clinical Solutions organization applies a drug-development mindset and collaborates across Functional Service Provider and Full-Service environments.
Syneos Health highlights career development and progression, supportive line management, technical and therapeutic-area training, peer recognition, total rewards, and an inclusive culture.
The company states that it has worked with 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years, according to the supplied posting.
REQUIRED VERIFIED SKILLS
Medical Writing
Clinical Narratives
Clinical Study Reports
CSR Narratives
Patient Narratives
Clinical Study Protocols
Protocol Amendments
Investigator Brochures
Clinical Data Interpretation
ICH-E3
FDA Regulations
ICH Guidelines
Clinical Research
Drug Development
English Grammar
Proofreading
Regulatory Writing
Narrative Drafting
Narrative Review
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated biopharmaceutical solutions organization. They provide end-to-end clinical and commercial solutions designed to accelerate the development and commercialization of new therapies worldwide. The company combines clinical development, medical affairs, and commercialization expertise to help clients bring innovative treatments to patients faster.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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