Senior Clinical Evaluation Medical Writer

8+ years

Not Disclosed

Hyderabad

10 Jan. 16, 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

Remote Type: Hybrid
Locations: Nanakramguda, Hyderabad, India
Time Type: Full-Time
Posted On: 13 Days Ago
Job Requisition ID: R14741

About Medtronic

At Medtronic, we pioneer innovation to address humanity’s toughest health challenges. Our mission is to alleviate pain, restore health, and extend life. With a global team of 90,000+ passionate individuals, we strive to engineer extraordinary solutions that improve lives.

A Day in the Life

The Senior Clinical Evaluation Medical Writer on the Endoscopy Clinical Evaluation team plays a critical role in drafting and maintaining clinical evaluation documents such as CEP, CER, PMCFP, PMCFR, and SSCP. These documents are essential for CE Marking of new devices and maintaining compliance for existing devices under MEDDEV 2.7/1 Rev 4 and EU Regulation 2017/745.

In this role, you will combine expertise in scientific methodology, medical device regulations, and data analysis to support regulatory submissions. You will collaborate cross-functionally to compile safety, performance, and risk/benefit data, ensuring alignment with regulatory requirements.

Key Responsibilities

Independently prepare and maintain clinical evaluation documents (CEP, CER, PMCFP, PMCFR, SSCP).
Identify, evaluate, and synthesize clinical evidence from preclinical studies, clinical investigations, and post-market surveillance.
Conduct literature searches and critically evaluate studies, summarizing data into formal reports.
Analyze complaints/adverse events from literature and report to GCH.
Create responses to audit/submission queries.
Maintain and update a database of peer-reviewed literature.
Develop state-of-the-art reviews for product families.
Review and align risk management files, IFUs, and cross-functional documentation.
Communicate timelines, project risks, and requirements to stakeholders.

Qualifications

Education:

Bachelor’s degree and 8 years of experience (minimum 4 years in a relevant field), OR advanced degree with 2 years of relevant experience.

Skills & Experience:

Mastery in medical/scientific writing, critical literature review, and data analysis.
In-depth knowledge of MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745, and related guidelines.
Familiarity with regulatory agency requirements for clinical evaluation.
Strong verbal and written communication skills.
Project management knowledge is a plus.

Physical Job Requirements

The outlined responsibilities and qualifications are not exhaustive but represent the general nature of the role.

Benefits & Compensation

Competitive salary and flexible benefits package.
Short-term incentive eligibility under the Medtronic Incentive Plan (MIP).
Resources and compensation plans designed to support employees throughout their career and life stages.

Learn More About Us

Medtronic is at the forefront of global healthcare technology, solving real-world health challenges. With a focus on diversity and innovation, we are committed to improving lives everywhere.

For more information about our business, mission, and commitment to diversity, click here.

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Senior Clinical Evaluation Medical Writer

Job Description

Senior Clinical Evaluation Medical Writer

About Medtronic

A Day in the Life

Key Responsibilities

Qualifications

Education:

Skills & Experience:

Physical Job Requirements

Benefits & Compensation

Learn More About Us

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