Tata Consultancy Services (TCS) is a global leader in IT services, consulting, and business solutions. With a deep commitment to innovation and excellence, TCS offers a supportive environment for professionals passionate about advancing healthcare and clinical research. Currently, TCS is seeking a Medical Writer in the Mumbai Metropolitan Region.
About the Role
The Medical Writer role at TCS is integral to the preparation of clinical and scientific documents required for regulatory submissions. This position demands a blend of technical expertise, attention to detail, and a strong grasp of clinical research standards.
Key Responsibilities
- Document Preparation
- Develop clinical documents for national and international regulatory submissions, adhering to the standards of the US, European, and other regulatory agencies.
- Writing and Review
- Create clear, concise, and scientifically sound documents with meticulous attention to detail.
- Review scientific and clinical documents to ensure quality and compliance.
- Domain Expertise
- Apply strong analytical skills in interpreting clinical research data.
- Leverage a comprehensive understanding of the Common Technical Document (CTD) structure, ICH-GCP principles, and regulatory requirements.
Skills and Qualifications
- Core Skills
- Expertise in scientific and clinical writing with a focus on precision and clarity.
- Strong analytical skills for interpreting and presenting clinical data.
- Attention to detail in reviewing complex medical documents.
- Domain Knowledge
- Familiarity with clinical research methodologies, ICH-GCP principles, and regulatory submission requirements.
- Proficiency in the CTD structure for regulatory filings.
- Experience
- Proven track record in creating regulatory documents for international markets.
