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Clinical Evaluation Medical Writerspecialist

4-7 years
Not Disclosed
10 April 7, 2025
Job Description
Job Type: Full Time Hybrid 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

 

Job Title: Clinical Evaluation Medical Writer Specialist-II

Company: Medtronic
Location: Nanakramguda, Hyderabad, India
Remote Type: Hybrid
Job Type: Full-Time
Job Requisition ID: R21455
Posted: 26 Days Ago


Job Overview

As a Clinical Evaluation Medical Writer at Medtronic, you’ll support regulatory and clinical documentation through critical evaluation of clinical evidence and scientific literature. This role requires strong analytical, writing, and communication skills and contributes to the preparation of documentation for regulatory authorities, audits, and internal stakeholders.


Key Responsibilities

  • Review, summarize, and critically appraise scientific literature.

  • Identify and report complaints/adverse events from literature to Global Complaint Handling (GCH).

  • Conduct comprehensive literature searches and maintain a peer-reviewed literature database.

  • Develop and maintain state-of-the-art documentation for product families and their intended use.

  • Create and maintain clinical evaluation plans and reports for regulatory submissions.

  • Respond to audit and submission queries effectively.

  • Review and approve documentation related to device development.

  • Ensure compliance with global clinical evaluation regulatory requirements.

  • Mentor or guide junior professionals, if applicable.

  • Collaborate with internal teams to ensure project milestones are achieved.


Skills & Competencies

  • Strong written, organizational, and communication skills.

  • Detail-oriented with strong multitasking and planning abilities.

  • Self-driven with a team-oriented mindset.

  • Excellent English proficiency (reading, writing, and speaking).

  • Strong learning attitude and ability to work under pressure.


Experience & Education

  • Education:

    • Bachelor’s degree in Medical, Mechanical, Electrical Life Sciences OR

    • Master’s in Pharmaceutical Sciences.

  • Experience:

    • 4–7 years of experience as a medical/clinical writer in the medical device and/or pharmaceutical industry.

    • A combination of experience in both is preferred.


Career Stream Classification

  • Specialist Career Stream:

    • Individual contributor with project responsibilities.

    • May mentor or guide junior professionals.

    • Expected to independently manage moderately complex assignments with minimal supervision.


Additional Information

  • Autonomy: Works independently with general supervision.

  • Organizational Impact: Contributes to completion of milestones.

  • Communication: Primarily internal communication for information sharing and problem-solving.

  • Travel: Not specified; assumed low due to hybrid setup.


Benefits & Compensation

  • Competitive salary and benefits package.

  • Flexible benefit options based on career and life stage.

  • Employee recognition and career development opportunities.


About Medtronic

Medtronic is a global leader in healthcare technology committed to alleviating pain, restoring health, and extending life. With a team of over 95,000 employees worldwide, Medtronic fosters innovation, collaboration, and professional development in pursuit of meaningful healthcare solutions.