Syneos Health is seeking candidates for the Medical Writer I (CSR Narrative) position in Hyderabad and Gurugram, India. The role focuses on clinical study report writing, patient narrative drafting, medical writing deliverables, and regulatory-compliant clinical documentation.
Candidates must have at least 1 year of medical writing and narrative writing experience and should be well versed in Clinical Study Report (CSR) narrative drafting and authoring. Applicants should also have strong English grammar, proofreading, and clinical research knowledge.
Job Details
| Job Detail | Information |
|---|---|
| Company | Syneos Health |
| Job Title | Medical Writer I (CSR Narrative) |
| Job Requisition ID | 25113241 |
| Job Locations | Hyderabad, Gurugram |
| Work Mode | Hybrid |
| Employment Type | Full-time |
| Minimum Experience | 1 year in medical writing and narrative writing |
| Key Requirement | CSR narrative drafting and authoring |
| Application | Online |
Position: Medical Writer I (CSR Narrative)
The Medical Writer I will compile, write, and edit clinical and medical writing documents under moderate supervision. The position involves preparing clinical study reports, patient narratives, clinical study protocols, protocol amendments, and investigator brochures while following applicable regulatory guidelines and company procedures.
Key Responsibilities
- Draft and author patient narratives and clinical study report (CSR) content.
- Compile, write, and edit medical writing deliverables.
- Develop or support clinical study protocols, protocol amendments, and investigator brochures.
- Review statistical analysis plans and table, figure, and listing specifications for content, grammar, formatting, and consistency.
- Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams.
- Follow ICH-E3 guidelines, applicable regulatory standards, company SOPs, client standards, and approved templates.
- Conduct online clinical literature searches when required.
- Maintain professional knowledge of regulatory guidance and client expectations.
- Complete assigned documentation and administrative tasks within specified timelines.
Eligibility and Qualifications
Candidates should meet the following requirements:
- At least 1 year of medical writing and narrative writing experience.
- Strong knowledge of CSR narrative drafting and authoring.
- A Bachelor of Science degree with relevant writing experience, or a Bachelor of Arts degree in Social Sciences, English, or Communications with relevant scientific or medical knowledge and expertise.
Understanding of FDA and ICH regulations and guidelines is strongly preferred.
Required Skills
- Excellent English grammar and proofreading skills.
- Familiarity with the AMA style guide.
- Understanding of clinical research principles.
- Ability to interpret and present clinical data and complex information.
- Strong presentation and interpersonal skills.
- Team-oriented approach to work.
- Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet applications.
- Ability to prepare accurate, consistent, and regulatory-compliant medical writing documents.
