Syngene International is seeking candidates for the Medical Writer position in its Discovery Services division. The role is based at Semicon Park, Electronic City Phase II, Bengaluru, and involves developing clinical and scientific documents, preparing regulatory submissions, reviewing study results, and ensuring compliance with medical writing standards.
The position involves working with clinicians, clinical scientists, biostatisticians, study teams, and internal and external clients to deliver accurate, high-quality medical writing documents across therapeutic areas and phases of clinical research.
Job Details
| Particulars | Details |
|---|---|
| Company | Syngene International |
| Job Title | Medical Writer |
| Division | Discovery Services |
| Job Location | Semicon Park, Electronic City Phase II, Bengaluru, India |
| Date Mentioned | 22 October 2026 |
Position: Medical Writer
The Medical Writer will independently develop, review, and finalize clinical, scientific, and regulatory documents while coordinating with study teams and ensuring compliance with applicable regulatory guidelines, standard operating procedures (SOPs), and client requirements.
Roles and Responsibilities
- Develop and finalize clinical and scientific documents, including study synopses, protocols, investigator brochures, clinical study reports (CSRs), informed consent documents (ICDs), and regulatory documents.
- Prepare eCTD modules and scientific communication materials, including abstracts, posters, presentations, and manuscripts.
- Conduct literature searches and reviews to support scientific content development.
- Collaborate with clinicians, clinical scientists, biostatisticians, and study teams to ensure accurate interpretation and presentation of study results.
- Ensure clinical documents accurately reflect data from tables, listings, figures (TLFs), and other information sources.
- Manage medical writing and review processes to deliver quality documents within agreed timelines.
- Follow applicable regulatory guidelines, departmental SOPs, and client style guides.
- Perform quality control checks, review drafts, edit documents, and address quality findings.
- Develop and maintain SOPs and work instructions for compliant medical writing deliverables.
- Identify improvements in document preparation processes and templates.
- Review documents prepared by junior team members and provide training and mentorship.
Eligibility and Qualifications
Candidates should have relevant expertise in medical writing and clinical or scientific document development. The supplied job description does not list specific educational qualifications or a minimum number of years of experience.
Required Skills
- Clinical and scientific writing
- Regulatory document preparation
- Clinical study report writing
- Literature search and review
- Scientific data interpretation
- Medical document editing and quality control
- Regulatory guideline and SOP compliance
- eCTD documentation
- Cross-functional collaboration
- Project and timeline management
- Training and mentoring junior team members
- Data integrity and workplace safety compliance
Safety and Quality Requirements
Syngene emphasizes safety, operational discipline, and compliance with its quality standards. Employees are expected to follow workplace safety protocols, comply with environmental, health, and safety requirements, and complete assigned mandatory training related to data integrity, health, and safety.
