Syneos Health Hiring Medical Writer I (CSR Narrative) in Hyderabad
Syneos Health is looking for a Medical Writer I (CSR Narrative) in Serilingampalli, Hyderabad, Telangana. You’ll need at least one year of experience in medical and narrative writing for clinical research and regulatory documents. Key tasks include writing CSR narratives, preparing clinical research documents, reviewing clinical data specs, and making sure all medical writing is accurate and consistent.
Job Details
| Job Information | Details |
| Company | Syneos Health |
| Position | Medical Writer I (CSR Narrative) |
| Department | Medical Writing / Clinical Research |
| Location | Serilingampalli, Hyderabad, Telangana |
| Experience | Minimum 1 year in medical writing and narrative writing |
| Qualification |
B.Sc. or relevant B.A. with scientific or medical knowledge
|
| Employment Type | Full-time |
| Work Arrangement | Verify on the official careers portal |
| Application Mode | Online |
Company Overview
Syneos Health is a global life sciences company that helps pharmaceutical and biotech companies with clinical development and bringing products to market. Their teams work with experts in clinical research, regulatory affairs, medical affairs, and more to support drug development and create clinical documents.
Job Role and Responsibilities
The Medical Writer puts together, writes, edits, and helps manage clinical and regulatory documents with some supervision. This job needs strong writing skills, a good understanding of clinical research, and the ability to understand complex scientific information.
1. CSR Narrative Writing
- Draft and author the Clinical Study Report (CSR) narratives.
- Prepare and edit patient reports and other clinical research documents.
- Make sure scientific information is clear, accurate, consistent, and well presented.
- Check documents for grammar, formatting, and overall quality.
2. Clinical and Regulatory Documentation
- Develop or support clinical study protocols and protocol amendments.
- Prepare clinical study reports and investigator brochures.
- Compile and edit medical writing deliverables for clinical studies and regulatory projects.
- Search for clinical literature online when needed.
3. Clinical Data Review
- Review statistical analysis plans and the specifications for tables, figures, and listings (TFLs).
- Check clinical data specifications for content, grammar, formatting, and consistency.
- Provide feedback to help clarify the statistical results needed for clinical documents.
- Interpret and present clinical data and other complex information.
4. Regulatory Compliance and Quality
- Follow all relevant regulatory guidelines, such as ICH-E3.
- Use company standard operating procedures, client standards, and approved templates.
- Ensure medical writing deliverables are completed on time and meet quality standards.
- Monitor project budgets and update medical writing leadership about any changes.
5. Cross-Departmental Collaboration
- Work with teams in Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
- Collaborate with clinical study and regulatory project teams to finish writing assignments.
- Stay updated on regulatory guidance and medical writing standards by continuing your professional development.
Eligibility Criteria
Educational Qualification
The employer accepts the following educational backgrounds:
- B.Sc. with relevant writing experience.
- B.A. in Social Sciences (English oB.A. in Social Sciences (English or Communications), or equivalent, preferably with some scientific or medical knowledge. or skills may be considered at the employer’s discretion.
Experience Requirements
- Minimum 1 year’s medical writing experience.
- Minimum 1 year’s experience in narrative writing.
- Practical knowledge of CSR narrative writing and authoring.
- Familiarity with the principles of clinical research and the interpretation of clinical data.
This is an entry-level medical writer position, but it is not for freshers. The employer requires some prior experience in medical and narrative writing.
Key Skills Required
Candidates should have the following skills:
- Clinical Study Report (CSR) narrative writing
- Patient narrative preparation
- Medical writing, editing, and proofreading
- Clinical research documentation
- Understanding of clinical data and statistical results
- ICH-E3 guidelines and familiarity with FDA requirements
- AMA style guide familiarity
- Scientific literature searching
- Microsoft Word, Excel, and PowerPoint
- Strong English grammar and written communication
- Attention to detail and document consistency
- Teamwork and coordination
How to Apply
If you’re interested, you can view the full job description and apply on the Syneos Health careers site.
Apply Online: Syneos Health Medical Writer I – CSR Narrative
Candidates should highlight their medical writing experience, CSR narrative authoring, and knowledge of clinical research documentation in their applications.
Job Summary
| Category | Details |
| Company | Syneos Health |
| Position | Medical Writer I (CSR Narrative) |
| Department | Medical Writing |
| Qualification |
B.Sc. or relevant B.A. with scientific or medical knowledge
|
| Experience | At least 1 year in medical writing and narrative writing |
| Location | Serilingampalli, Hyderabad, Telangana |
| Key Skills | CSR narratives, patient narratives, clinical documentation, ICH-E3 |
| Employment Type | Full-time |
| Apply Mode | Online |