Syneos Health is hiring for Medical Writer I / Medical Writer II (CSR Narratives) in India. The positions involve compiling, writing, editing, and reviewing medical writing deliverables, including clinical study reports, patient narratives, clinical study protocols, annual reports, and investigator brochures.
The roles are available as Remote (Pre-Approved) and Gurugram-Hybrid positions.
Job Details
| Details | Information |
|---|---|
| Company | Syneos Health |
| Job Title | Medical Writer I / Medical Writer II (CSR Narratives) |
| Job Location | IND-Remote / IND-Gurugram-Hybrid |
| Work Mode | Remote (Pre-Approved) / Hybrid |
| Employment Type | Full Time |
| Job Requisition ID | 25111845 |
Positions
- Medical Writer I
- Medical Writer II
Job Responsibilities
- Compile, write, and edit medical writing deliverables with minimal supervision.
- Develop clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures.
- Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams.
- Perform peer reviews and address comments related to scientific content, clarity, consistency, and formatting.
- Follow regulatory standards including ICH-E3 guidelines, company SOPs, client standards, and approved templates.
- Conduct online clinical literature searches when required.
- Mentor less experienced medical writers on projects, as necessary.
- Maintain knowledge of the drug development process and regulatory guidelines.
- Work within assigned project budgets and communicate changes to medical writing leadership.
- Complete administrative tasks within specified timeframes.
- Minimal travel may be required, less than 25%.
Eligibility / Qualifications
Candidates should meet the following experience and educational requirements:
- Minimum 1 year of experience working in narratives with a Master’s qualification.
- 2 years of experience with a bachelor’s degree.
- Postgraduate qualification such as Master’s / M.Pharm, or a bachelor’s degree.
- Good experience in drafting and reviewing narratives.
- Familiarity with clinical research principles and the ability to interpret and present clinical data and complex information.
Required Skills
- Medical writing
- Patient and clinical narratives
- Clinical study reports
- Strong English grammar
- Knowledge of FDA and ICH regulations and guidelines
- Familiarity with the AMA style guide
- Proofreading and presentation skills
- Strong interpersonal and leadership skills
- Microsoft Word, Excel, and PowerPoint
- Email and Internet proficiency
- Ability to interpret clinical data
- Team-oriented approach
- Ability to work independently
Application Details
