Tata Elxsi Clinical Specialist Medical Writer
- Tata Elxsi Hiring Clinical Specialist (Medical Writer) | High-Paying Clinical Writing Roles in India
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Qualification:
- Relevant Courses:
- Experience:
- Required Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Who can apply for this role?
- Is EU MDR knowledge mandatory?
- What does a Clinical Medical Writer do?
- What is the experience required?
- What is the job location?
Tata Elxsi Hiring Clinical Specialist (Medical Writer) | High-Paying Clinical Writing Roles in India
Tata Elxsi is hiring experienced professionals for the role of Clinical Specialist (Clinical Medical Writer) across Bengaluru, Pune, and Hyderabad locations. This is a high-impact opportunity in the medical device and clinical regulatory domain for candidates with 5 to 15 years of experience. The role focuses on clinical evaluation reports (CERs), post-market surveillance, and regulatory documentation aligned with global standards like EU MDR and MDD.
This is a premium career opportunity for professionals aiming to advance in medical writing, clinical evaluation, and regulatory affairs within the medical device and life sciences industry.
Company Overview
Tata Elxsi, a part of the Tata Group, is a leading global design and technology services company with a strong presence in healthcare, life sciences, and medical device engineering. The company works with global pharmaceutical and medtech companies to deliver solutions in regulatory affairs, clinical research, digital health, and product engineering.
With deep expertise in EU MDR compliance, clinical evaluation, and healthcare innovation, Tata Elxsi provides professionals with exposure to global regulatory frameworks and advanced clinical documentation practices. The company is known for its collaborative culture, innovation-driven approach, and strong growth opportunities.
Job Role & Responsibilities
As a Clinical Specialist (Medical Writer), you will be responsible for developing and reviewing high-quality clinical and regulatory documents required for medical device approvals and lifecycle management.
Key Responsibilities:
Clinical & Regulatory Writing
- Author Clinical Evaluation Reports (CERs) in compliance with EU MDR (MEDDEV 2.7/1 Rev 4)
- Develop Post-Market Clinical Follow-up (PMCF) plans and reports
- Prepare post-marketing surveillance and risk management documentation
- Support preparation of clinical evidence and regulatory submission documents
Literature Review & Data Analysis
- Conduct literature searches for medical devices and therapeutic areas
- Analyze and summarize clinical data, risks, and alternative therapies
- Interpret scientific literature to support clinical evaluation and risk assessment
Collaboration & Stakeholder Management
- Work cross-functionally with clinical, regulatory, and product teams
- Participate in client discussions and project meetings
- Ensure timely delivery of documents aligned with project timelines
Documentation & Quality Control
- Perform proofreading, editing, and formatting of regulatory documents
- Integrate review comments and finalize documents for submission
- Maintain high standards of accuracy, compliance, and presentation quality
Eligibility / Qualifications
Educational Qualification:
Bachelor’s or Master’s degree in Biomedical Sciences, Life Sciences, or related fields
Relevant Courses:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Biomedical Engineering, Clinical Research, Medical Writing
Experience:
- 5 to 15 years of experience in clinical evaluation, medical writing, or regulatory affairs
- Strong experience in CER writing and EU MDR/MDD compliance is required
Required Skills
- Strong expertise in clinical evaluation and medical device regulations
- Excellent scientific writing and documentation skills
- Ability to interpret complex clinical and regulatory data
- Strong analytical and problem-solving capabilities
- Experience with literature review and clinical data analysis
- Proficiency in Microsoft Office tools
Location & Salary
- Job Location: Bengaluru, Pune, Hyderabad
- Work Mode: On-site
- Salary: High-paying package based on experience and industry standards in medical writing and regulatory affairs
Application Process
Interested candidates can apply through the official LinkedIn job posting:
Apply Here: https://www.linkedin.com/jobs/view/4395948480/
Frequently Asked Questions (FAQs)
Who can apply for this role?
Candidates with Life Sciences or Biomedical degrees and relevant experience in medical writing or clinical evaluation can apply.
Is EU MDR knowledge mandatory?
Yes, knowledge of EU MDR/MDD regulations is important for this role.
What does a Clinical Medical Writer do?
They prepare clinical evaluation reports, regulatory documents, and analyze clinical data for medical devices.
What is the experience required?
Candidates must have 5 to 15 years of relevant experience.
What is the job location?
The role is available in Bengaluru, Pune, and Hyderabad.
| Category | Details |
|---|---|
| Company | Tata Elxsi |
| Vacancies | Clinical Specialist (Medical Writer) |
| Required Education | Life Sciences / Biomedical Sciences |
| Experience | 5–15 Years |
To apply for this job please visit www.linkedin.com.
