Clinical Evaluation Medical Writer at Medtronic

Milan, Lombardy, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Advanced education (implied by Specialist Career Stream)
Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements
Ability to work independently with general supervision on larger, moderately complex projects/assignments
Established and productive individual contributor experience
Ability to set objectives for own job area to meet project goals
Capability to contribute to project milestones and cross-functional assignments
Understanding of broader issues across job areas to solve general problems
Ability to make adjustments or recommend enhancements in systems and processes
Strong communication skills for internal contacts and sharing information/status/needs/issues
Ability to provide guidance to entry-level professionals

Responsibilities

Review and summarize scientific literature
Report instances of complaints/adverse events from literature to GCH
Create responses for audit/submission queries
Maintain database of peer-reviewed literature
Appraise, analyze, summarize, and discuss clinical evidence from all available sources
Conduct comprehensive literature searches and perform critical evaluation of clinical evidence
Develop state of the art on product family for its intended purpose
Create and maintain plans and reports for regulatory authorities
Review/approve other documentation for device development

Skills

scientific literature review

clinical evidence analysis

literature search

regulatory submissions

GCP

medical device documentation

peer-reviewed literature database

audit responses

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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