Medtronic is inviting applications for the position of Clinical Evaluation Medical Writer in Nanakramguda, Hyderabad, Telangana, India. The role focuses on preparing clinical evaluation reports, reviewing scientific literature, analyzing clinical evidence, and supporting regulatory documentation for medical devices and pharmaceutical products.
Candidates with relevant postgraduate qualifications in pharmacy, life sciences, nursing, medicine, or pure and applied sciences, along with 4–8 years of medical or clinical writing experience, can review the eligibility requirements.
Job Details
| Particulars | Details |
|---|---|
| Company | Medtronic |
| Job Title | Clinical Evaluation Medical Writer |
| Job Location | Nanakramguda, Hyderabad, India |
| Work Arrangement | Flexible Work Arrangement |
| Job Type | Full Time |
| Experience | 4–8 years |
| Requisition ID | R72925 |
| Industry | Medical Devices / Healthcare Technology |
| Salary & Compensation | Competitive compensation package and Medtronic Incentive Plan (MIP) |
Position
Clinical Evaluation Medical Writer
The selected candidate will prepare and maintain clinical evaluation plans and reports, Summary of Safety and Clinical Performance reports, and other clinical and regulatory documents supporting medical device safety, performance, and regulatory submissions.
Responsibilities
- Prepare, edit, and review Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), clinical study reports, and Summary of Safety and Clinical Performance (SSCP) reports.
- Support Periodic Safety Update Reports (PSURs) and responses to Notified Body questions.
- Conduct comprehensive scientific literature searches and critically evaluate clinical evidence.
- Maintain databases of peer-reviewed literature and relevant clinical evidence.
- Prepare scientific manuscripts, abstracts, reports, summaries, and regulatory documentation.
- Collaborate with cross-functional teams to analyze medical device safety and performance data.
- Monitor changes in safety regulations, guidance documents, and industry standards.
- Apply relevant quality and regulatory standards, including ISO 13485, ISO 14971, EU MDR, and applicable US regulations.
Eligibility and Educational Qualifications
Candidates must hold one of the following relevant qualifications:
- B.Pharm + M.Pharm
- M.Sc. or a Master’s degree in Pure or Applied Sciences
- Master’s degree in Biochemistry
- Master’s degree in Biotechnology
- Master’s degree in Microbiology
- Master’s degree in Nursing
- Other relevant Life Sciences postgraduate qualifications
- MBBS
- Doctorate in Pure or Applied Sciences
Experience required: 4–8 years as a medical or clinical writer in the medical device and/or pharmaceutical industry. A combination of experience across both industries is preferred for candidates from the pharmaceutical sector.
Required Skills and Knowledge
- Medical and clinical writing for regulatory documentation.
- Knowledge of US and EU quality systems regulations.
- Understanding of ISO 13485 and ISO 14971.
- Knowledge of 21 CFR Part 820 and 21 CFR Part 11.
- Familiarity with EU MDR and product-specific industry standards.
- Scientific literature searching and critical appraisal of clinical evidence.
- Strong written, verbal, organizational, and communication skills.
- Attention to detail, planning, and time management.
- Ability to manage multiple priorities under time-sensitive conditions.
- Proficiency in English and commitment to continuous professional development.
Preferred Qualifications
- Experience working with global and cross-functional teams.
- Relevant medical writing industry certifications.
Application Details
