Syngene International Ltd. is a leading global contract research and manufacturing organization (CRMO) providing integrated scientific services to pharmaceutical, biotechnology, nutrition, and animal health industries. Established in 1993, Syngene works with top-tier clients like Bristol-Myers Squibb, Amgen, GSK, Merck KGaA, and Herbalife. With a team of over 4,240 scientists, Syngene is committed to accelerating drug discovery, improving R&D productivity, and reducing innovation costs.
Job Description: Medical Writer
Key Responsibilities:
- Develop and finalize clinical and scientific documents for regulatory submissions, including:
- Bioanalytical reports
- Clinical Study Reports (CSRs)
- Electronic Common Technical Document (eCTD) modules
- Collaborate with internal and external teams to ensure clear and effective communication.
- Manage medical writing and review processes to meet timelines and quality standards.
- Ensure compliance with regulatory guidelines, SOPs, and client-specific style guides.
- Perform quality control (QC) checks on documents and address feedback.
- Conduct literature searches to gather scientific background information.
- Follow environment, health, and safety (EHS) policies.
Educational Qualifications:
- Bachelor’s degree in Life Sciences (Mandatory)
- Master’s degree in Life Sciences (Preferred)
Experience Required:
- 1-4 years in medical writing or related fields.
Skills Required:
Behavioral Skills:
- Strong communication skills
- Quick learner with adaptability
- Excellent time management
- High level of professionalism
Technical Skills:
- Ability to interpret scientific data
- Understanding of clinical research processes
- Proficiency in MS Word, PowerPoint
- Knowledge of regulatory guidelines (ICH-GCP, FDA, EMA)
Why Join Syngene?
- Work with global pharmaceutical leaders.
- Be part of an innovation-driven scientific community.
- Career growth opportunities in medical writing and regulatory affairs.
- Inclusive workplace with equal opportunity employment.
