Syneos Health Hiring Medical Writer II (CSR Narrative) in Hyderabad
Syneos Health is recruiting for a Medical Writer II (CSR Narrative) position in Hyderabad, Telangana. This opportunity is suitable for medical writing professionals with 2–4 years of medical writing experience, including at least 1 year of patient narrative writing experience. The role focuses on drafting and authoring clinical study report (CSR) narratives, preparing clinical and regulatory documents, and ensuring scientific accuracy and compliance with applicable regulatory guidelines.
Company Overview
Syneos Health is a global life sciences services organization supporting pharmaceutical and biotechnology companies across clinical development and commercialization. Its clinical solutions teams work with clients and cross-functional experts to help advance drug development programs and deliver clinical and regulatory documentation.
Job Details
| Job Information | Details |
|---|---|
| Company | Syneos Health |
| Position | Medical Writer II (CSR Narrative) |
| Department | Medical Writing / Clinical Research |
| Location | Hyderabad, Telangana, India |
| Work Mode | On-site, according to the supplied LinkedIn listing |
| Employment Type | Full-time |
| Experience | 2–4 years in medical writing |
| Specific Experience | At least 1 year in narrative writing |
| Application Mode | Online |
Job Role and Responsibilities
The Medical Writer II will prepare, review, edit, and coordinate clinical and regulatory documents, with a particular focus on clinical study report narratives. The role requires strong scientific writing skills, attention to detail, and familiarity with clinical research and regulatory requirements.
1. CSR and Patient Narrative Writing
- Draft and author clinical study report (CSR) narratives.
- Prepare and edit patient narratives and other clinical documentation.
- Ensure narratives accurately reflect clinical data and maintain consistency with source information.
- Review documents for scientific accuracy, clarity, grammar, formatting, and consistency.
2. Clinical and Regulatory Document Preparation
- Prepare or support the development of clinical study protocols and protocol amendments.
- Contribute to clinical study reports, annual reports, and investigator brochures.
- Compile, write, and edit medical writing deliverables with minimal supervision.
- Conduct clinical literature searches when required for assigned projects.
3. Clinical Data Review
- Review statistical analysis plans and table, figure, and listing (TFL) specifications for content, grammar, formatting, and consistency.
- Interpret clinical data and communicate complex scientific information clearly.
- Coordinate with data management, biostatistics, regulatory affairs, and medical affairs teams to complete writing assignments.
4. Quality Assurance and Regulatory Compliance
- Follow applicable regulatory requirements, including ICH-E3 guidance, company standard operating procedures, client standards, and approved templates.
- Participate in peer reviews and address reviewer comments accurately.
- Maintain high standards of scientific quality, consistency, and document presentation.
- Complete assigned deliverables within agreed timelines and budgets.
5. Team Collaboration and Mentoring
- Work with clinical study and regulatory project teams to coordinate documentation activities.
- Mentor less experienced medical writers when required.
- Maintain professional knowledge of changing regulatory guidance and client expectations.
- Complete project administration and other assigned responsibilities.
Limited travel may be required, with the supplied job description indicating less than 25%.
Eligibility Criteria
Educational Qualification
The employer lists the following educational backgrounds:
- Bachelor of Science with relevant writing experience.
- Bachelor of Arts in Social Sciences, English, or Communications, preferably with relevant scientific or medical knowledge.
Equivalent education, skills, or experience may also be considered at the employer’s discretion.
Experience Requirements
Candidates should have:
- 2–4 years of medical writing experience.
- At least 1 year of narrative writing experience.
- Practical experience drafting and authoring CSR narratives.
- Familiarity with clinical research and the drug development process.
- Working knowledge of applicable regulatory guidelines.
The key requirement is demonstrated CSR narrative writing experience, rather than general writing experience alone.
Key Skills Required
Candidates should possess the following skills and knowledge:
- Clinical Study Report (CSR) narrative writing
- Patient narrative drafting and authoring
- Medical writing and scientific editing
- Clinical research documentation
- ICH-E3 guidelines and regulatory requirements
- FDA regulations and guidance
- AMA style guide familiarity
- Clinical data interpretation
- Statistical analysis plans and TFL specifications
- Literature searches and scientific information review
- Grammar, proofreading, and document quality control
- Microsoft Word, Excel, and PowerPoint
- Communication, organization, and project coordination
How to Apply
Interested candidates can review the official job listing and submit their applications through the Syneos Health careers portal.
Apply Online: Syneos Health Medical Writer – CSR Narrative
Important: The supplied LinkedIn listing identifies the role as Medical Writer II and on-site, while the application URL contains the title “Medical Writer-I” and identifies the location as Hyderabad Hybrid. Verify the exact designation and work arrangement on the official careers page before applying.
Job Summary
| Category | Details |
|---|---|
| Company | Syneos Health |
| Position | Medical Writer II (CSR Narrative) |
| Department | Medical Writing |
| Qualification | B.Sc. or B.A. in a relevant discipline, or equivalent qualifications accepted by the employer |
| Experience | 2–4 years in medical writing; at least 1 year in narrative writing |
| Location | Hyderabad, Telangana |
| Key Skills | CSR narratives, patient narratives, ICH-E3, clinical documentation |
| Employment Type | Full-time |
| Apply Mode | Online |