Syneos Health is hiring Medical Writer I / Medical Writer II – CSR Narratives professionals in India. This opportunity is suitable for candidates with experience in drafting and reviewing patient narratives, clinical study reports (CSR), clinical research documentation, and regulatory medical writing.
The Medical Writer will support the development and review of clinical and regulatory documents while working with cross-functional teams including biostatistics, data management, regulatory affairs, and medical affairs.
Candidates with a Bachelor’s or Master’s degree, including relevant postgraduate or M.Pharm qualifications, may be considered based on their experience and alignment with the employer’s requirements.
Key Responsibilities
As a Medical Writer I/II at Syneos Health, selected candidates may be responsible for:
- Compile, write, review, and edit clinical and regulatory medical writing deliverables.
- Draft and review patient narratives and CSR narratives.
- Develop clinical study protocols and protocol amendments.
- Prepare and support Clinical Study Reports (CSRs).
- Contribute to annual reports and Investigator’s Brochures.
- Review statistical analysis plans and table, figure, and listing specifications.
- Check documents for scientific accuracy, grammar, consistency, formatting, and clarity.
- Collaborate with data management, biostatistics, regulatory affairs, medical affairs, and other project stakeholders.
- Participate in internal peer reviews and appropriately address reviewer comments.
- Follow ICH-E3 guidelines, applicable regulatory standards, SOPs, client requirements, and approved document templates.
- Conduct online clinical literature searches when required.
- Apply knowledge of the drug development process and regulatory guidelines.
- Complete medical writing projects within assigned timelines and budgeted hours.
- Mentor less-experienced medical writers when required.
- Maintain professional knowledge of evolving regulatory guidance and medical writing practices.
Qualification & Experience
Syneos Health states that applicants should have a postgraduate/Master’s/M.Pharm or Bachelor’s degree.
The experience requirement specified in the job description is:
- Master’s/Postgraduate qualification: Minimum 1 year of relevant narrative writing experience.
- Bachelor’s/Graduate qualification: Minimum 2 years of relevant experience.
- Candidates should have good experience in drafting and reviewing narratives.
Equivalent combinations of education, skills, and experience may also be considered by Syneos Health according to its recruitment criteria.
Skills Required for Medical Writer – CSR Narratives
Candidates should have strong knowledge or experience in:
- CSR and patient narrative writing
- Medical and scientific writing
- Clinical research principles
- Clinical data interpretation
- ICH guidelines, including ICH E3
- FDA regulations and guidelines
- English grammar and scientific communication
- Proofreading and document quality review
- AMA style conventions
- Clinical study documentation
- Drug development processes
- Microsoft Word, Excel and PowerPoint
- Literature searching
- Cross-functional communication
- Regulatory document preparation
The role requires the ability to understand complex clinical information and convert it into clear, scientifically accurate, consistent, and regulatory-compliant documentation.
Why Consider This Syneos Health Medical Writer Role?
Syneos Health highlights several employee development opportunities, including:
- Career development and progression opportunities
- Technical and therapeutic-area training
- Supportive line management
- Peer recognition and total rewards programs
- Exposure to global clinical development projects
- Collaboration with multidisciplinary clinical research teams
- Remote and hybrid working arrangements depending on the assigned position
The company states that its teams have supported a substantial proportion of novel FDA-approved drugs and EMA-authorized products over recent years, providing medical writers exposure to global drug-development programs.
Estimated Salary
The employer has not disclosed a salary range in the provided job advertisement.
For structured-data purposes, an estimated market range of approximately ₹5,00,000 to ₹11,00,000 per year may be used as a broad editorial estimate for Medical Writer I/II roles in India.
Important: This is not an official Syneos Health salary disclosure. Actual compensation can vary based on role level, experience, location, skills, internal compensation structure, and interview outcome.
How to Apply
