Instagram
youtube
Facebook

Senior Clinical Evaluation Medical Writer

8+ years
₹14 – ₹23 LPA
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Evaluation Medical Writer – Hybrid – Hyderabad (Nanakramguda)
Location: Nanakramguda, Hyderabad, India
Job Type: Full-Time | Hybrid
Requisition ID: R37815
Posted: 15 Days Ago


About the Role:
Medtronic is seeking a Senior Clinical Evaluation Medical Writer to join the Endoscopy team, contributing to the creation, revision, and maintenance of clinical documentation for CE Mark submissions and compliance with EU MDR 2017/745. This role requires deep scientific writing expertise, a firm grasp of EU regulations, and the ability to collaborate across functions.


Key Responsibilities:

  • Develop and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up Plans (PMCFPs), Reports (PMCFRs), and SSCPs in compliance with MEDDEV 2.7/1 Rev 4, EU MDR 2017/745, and internal procedures.

  • Conduct literature reviews and analyze clinical, safety, and performance data to support regulatory submissions and lifecycle documentation.

  • Support Medical Information operations by tracking inquiries, creating literature-based responses, and managing documentation.

  • Review abstracts, posters, slide decks, manuscripts, and promotional materials to ensure regulatory and scientific accuracy.

  • Collaborate with Regulatory Affairs, Clinical Affairs, Quality, and Risk Management teams to ensure alignment on product risk and safety data.

  • Identify and escalate adverse events/complaints from literature to the Global Complaint Handling team.

  • Develop state-of-the-art reports and ensure accuracy of IFUs, risk management files, and labeling content.

  • Maintain databases of peer-reviewed literature and respond to audit and regulatory authority queries.

  • Communicate progress, deadlines, and challenges with stakeholders in a proactive and timely manner.


Required Qualifications:

  • Bachelor’s degree with 8+ years of total experience including minimum 4 years of relevant experience, or Master’s/advanced degree with 2+ years of relevant experience.

  • Mastery of clinical evaluation processes, literature review methods, and regulatory documentation under EU MDR.

  • Familiarity with project management practices.

  • Excellent command of scientific writing, critical data analysis, and literature synthesis.


Preferred Skills:

  • Expertise in medical devices or endoscopy domain.

  • Experience working with cross-functional global teams.

  • Strong attention to detail and ability to simplify complex data into clear, compliant documentation.


Work Environment:

  • Hybrid work model with flexibility to operate from Medtronic’s Hyderabad campus.

  • Role requires working collaboratively across global time zones.


Benefits & Compensation:

  • Competitive salary and Medtronic Incentive Plan (MIP) eligibility.

  • Extensive benefits package including health, wellness, stock purchase, and career development.

  • Inclusive and innovative workplace focused on diversity, collaboration, and professional growth.


About Medtronic:
With a mission to alleviate pain, restore health, and extend life, Medtronic leads global healthcare innovation. Home to 95,000+ professionals worldwide, the company blends advanced R&D with patient-first principles to develop technologies that change lives. At Medtronic, you don’t just work on medical solutions—you engineer the extraordinary.


Estimated Salary: ₹14 – ₹23 LPA (based on experience and industry benchmarks)