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Clinical Evaluation Medical Writerspecialist

4-7 years
Not Disclosed
10 March 28, 2025
Job Description
Job Type: Full Time Education: B.Tech/BCS/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

Clinical Evaluation Medical Writer Specialist - Hybrid, Hyderabad
 

Company: Medtronic
Location: Nanakramguda, Hyderabad, India
Type: Full-time, Hybrid
Job ID: R21455

Introduction:

Medtronic is committed to transforming healthcare with a focus on innovation, equity, and patient care. Our mission is to alleviate pain, restore health, and extend life. We are seeking a Clinical Evaluation Medical Writer Specialist-II to contribute to our mission while advancing their own career.


Role Overview:

The Clinical Evaluation Medical Writer Specialist-II will be responsible for analyzing and summarizing clinical evidence, developing regulatory reports, and maintaining clinical documentation. This role requires expertise in clinical writing, regulatory knowledge, and strong communication skills.


Key Responsibilities:

  • Review and summarize scientific literature.

  • Report instances of complaints/adverse events from literature to GCH.

  • Create responses for audit/submission queries.

  • Maintain a database of peer-reviewed literature.

  • Appraise, analyze, and summarize clinical evidence from available sources.

  • Conduct comprehensive literature searches and perform critical evaluations of clinical data.

  • Develop and maintain plans and reports for regulatory authorities.

  • Review and approve documentation related to device development.

  • Ensure compliance with regulatory guidelines for clinical evaluations.


Minimum Qualifications:

  • Education: Bachelor’s degree in Medical, Mechanical, Electrical Life Science, or Master’s in Pharmaceutical.

  • Experience:

    • 4-7 years of experience as a medical/clinical writer in the medical device and/or pharmaceutical industry (a combination of both preferred).

    • Strong organizational, written, and verbal communication skills.

    • Strong attention to detail and ability to manage multiple tasks effectively.

  • Skills:

    • Ability to work under pressure and meet deadlines.

    • Good knowledge of English (reading, writing, and speaking).

    • Strong analytical skills and good learning attitude.


Desired Characteristics:

  • Ability to work independently with general supervision on larger, moderately complex projects.

  • Strong project management skills and adherence to SDLC methodologies.

  • Ability to communicate effectively across internal teams.

  • Experience providing guidance and assistance to entry-level professionals.


Why Join Medtronic?

  • Career growth through award-winning development programs.

  • Competitive salary and flexible benefits.

  • Opportunity to work in a mission-driven, innovative environment.


About Medtronic:

Medtronic is a global leader in healthcare technology, addressing the most challenging health problems with innovative solutions. With over 95,000 employees worldwide, we are united by our mission to improve lives through cutting-edge technology and compassion.

Apply today to join us in shaping the future of healthcare.