Are you passionate about advancing healthcare through meticulous clinical evaluation and medical writing? Medtronic, a global leader in healthcare technology, is seeking a skilled Clinical Evaluation Medical Writer to join their team in Mumbai, Maharashtra, India. This full-time, remote position offers a unique opportunity to contribute to life-changing medical innovations while working with a dynamic, mission-driven organization dedicated to alleviating pain, restoring health, and extending life. If you have a knack for analyzing clinical evidence and crafting regulatory documents, this role is your chance to shine.
Responsibilities
As a Clinical Evaluation Medical Writer at Medtronic, you will play a pivotal role in ensuring compliance with regulatory standards and supporting the development of cutting-edge medical devices. Key responsibilities include:
- Literature Review and Analysis: Conduct comprehensive literature searches, critically evaluate clinical evidence, and summarize findings from peer-reviewed sources.
- Regulatory Documentation: Create and maintain clinical evaluation plans and reports for regulatory authorities, ensuring compliance with global guidelines.
- Adverse Event Reporting: Identify and report complaints or adverse events from scientific literature to the Global Complaint Handling (GCH) team.
- Query Response: Develop clear, concise responses to audit and submission queries from regulatory bodies.
- Database Management: Maintain an organized database of peer-reviewed literature to support clinical evaluations.
- Cross-Functional Collaboration: Review and approve documentation for device development, collaborating with R&D and regulatory teams.
- State-of-the-Art Development: Develop state-of-the-art reports on product families for their intended clinical purposes.
Qualifications
To excel in this role, candidates must demonstrate a blend of education, experience, and skills in clinical evaluation and medical writing. Required qualifications include:
- Education: A Baccalaureate degree (or equivalent for degrees earned outside the U.S., per 8 C.F.R. § 214.2(h)(4)(iii)(A)) in a relevant field such as life sciences, biomedical engineering, or a related discipline.
- Experience: Minimum of 2 years of relevant experience in clinical evaluation or medical writing, or an advanced degree (e.g., Master’s or PhD) with 0 years of experience.
- Skills: Practical knowledge of clinical evaluation processes, familiarity with regulatory guidelines (e.g., EU MDR, FDA), and proficiency in conducting literature searches and critical appraisals.
- Autonomy: Ability to work independently on moderately complex projects with general supervision, setting objectives to meet project milestones.
- Communication: Strong communication skills to interact with internal stakeholders and support decision-making.
- Leadership: Potential to mentor entry-level professionals or guide lower-level team members in the Support Career Stream.
Benefits
Medtronic values its employees and offers a competitive salary along with a flexible benefits package designed to support you at every stage of your career and life. Benefits include:
- Competitive Compensation: Attractive salary range of INR 8,00,000 to INR 12,00,000 per annum, commensurate with experience.
- Flexible Work Environment: Fully remote role, allowing you to work from anywhere in India while maintaining work-life balance.
- Career Growth: Opportunities for professional development, mentorship, and involvement in cross-functional projects.
- Comprehensive Benefits: Access to health, wellness, and financial resources to support your personal and professional well-being.
- Mission-Driven Culture: Join a global team of 95,000+ passionate individuals committed to transforming healthcare.
How to Apply
