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Medtronic
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Senior Clinical Evaluation Medical Writer

Senior Clinical Evaluation Medical Writer

Medtronic

8 - 13 years

20 - 25 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

Data analysis Claims Scientific writing Compliance Project management Healthcare market data Risk management Monitoring Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

A Day in the Life The Clinical Evaluation Medical Writer on our Endoscopy team plays a key role in developing and updating clinical evaluation documents (e.g., CEP, CER, PMCFP, PMCFR, SSCP) to support CE Mark submissions and maintain compliance throughout the product lifecycle. This work follows MEDDEV 2.7/1 Rev. 4 and EU Regulation 2017/745 and involves close collaboration with cross-functional teams to gather and interpret data on device safety, performance, and benefit-risk.
In addition, the writer supports related activities such as summarizing and disseminating clinical literature and other available data to share relevant evidence, while also managing Medical Information activities. This includes tracking inquiries, monitoring key metrics, researching and responding to technical and clinical questions from both internal teams and external healthcare professionals, all under the appropriate guidance of Clinical and Medical Affairs. Success in this role requires strong skills in scientific writing, literature review, data analysis, and clear communication, along with a proactive and collaborative mindset.

Responsibilities may include the following and other duties may be assigned.

Independently creates and maintains clinical evaluation documents (CEP, CER, PMCFP, PMCFR, SSCP) in compliance with MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, MDCG guidance, and company procedures.
Supports Medical Information activities by leveraging scientific expertise to research and respond to inquiries from healthcare professionals and internal teams, maintaining related documents and reports.
Performs thorough literature searches and reviews clinical evidence from studies, reports, and available post-market data. Summarizes and combines this information to support product submissions, clinical evaluations, and Medical Information inquiries.
Reviews scientific materials like abstracts, posters, manuscripts, slides, and promotional content to check for accuracy, proper claims, off-label use, and compliance with company policies.
Develops state-of-the-art reports for product families and reviews cross-functional documents such as IFUs and Risk Management files to ensure alignment on safety and risk information.
Identifies and reports complaints or adverse events from literature to the Global Complaint Handling team.
Creates responses to audit and submission queries and maintains a database of peer-reviewed literature.
Collaborates with key stakeholders to drive evidence-based scientific decisions and maintain compliance with regulatory and corporate guidelines.
Communicates project timelines, input requirements, and risks clearly and promptly with cross-functional teams.

Required Knowledge and Experience:

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
May have broad knowledge of project management.
Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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Senior Clinical Evaluation Medical Writer