Careers that Change Lives

In this exciting role as an Associate Clinical Evidence Specialist, you will primarily focus on developing clinical evaluation plans and managing associated deliverables for the Cardiac Rhythm Management (CRM) organization. This includes partnering with a wide variety of cross functional stakeholders to support ongoing data reviews and scientific assessments. This role provides scientific and/or medical expertise, analytical thought processes and a robust, systematic clinical evaluation approach to continuously collect, analyze, and assess clinical data on CRM products throughout their lifecycle.

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, and Cardiac Diagnostic Services. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures, and deliver successful patient outcomes.

We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader - that's why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion & Diversity at Medtronic Click Here

Location: Mounds View, MN.

Ability to travel up to 10%.

A Day in the Life

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

• Creating/populating template content for project leads in accordance with QMS and policy standards
• With appropriate supervision and support from project lead, assist in developing and providing medical writing support for clinical evaluation documents such as Clinical Evaluation Plans and Reports, Post-Market Clinical Follow-up plans and reports, and more, in compliance with regulations and Medtronic policies and procedures.
• Conduct literature reviews and data extraction under supervision of project lead. May assist with facilitating cross-functional review team kick-off and conclusion meetings, and training for project leads
• With appropriate supervision and support, assist in reviewing and summarizing data from multiple sources (clinical investigation results, scientific literature and clinical experience, preclinical data, etc.) in order to evaluate product safety, performance and clinical benefits and identify potential evidence gaps.
• Report instances of device complaints/adverse events from literature to GCH.
• Perform quality control check, compilation, formatting, and tabulation on clinical evaluation documents, as requested. Confirm data consistency and integrity across clinical evaluation documents.
• Coordinate the distribution of draft and final clinical evaluation documents to project team. Route final documents for approval and storage with appropriate database following good documentation practices.
• Create and manage project schedule for assigned documents in collaboration with project lead
• Develop sound knowledge of global clinical evaluation regulations and regulatory agencies' guidelines on clinical evaluation requirements.
• May develop best practice guidelines/checklists for ensuring review comments are vetted and complete in partnership with team
• May lead the development of policies, procedures, and/or process improvement initiatives for the group or clinical department.

Must Have: Minimum Requirements

• Bachelors degree required
• 0 years of experience

• Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRM therapies and technologies
• Project management experience
• Experience with medical and/or scientific writing at Medtronic or within the medical device/pharmaceutical industry
• Demonstrated ability to work in a matrixed, global environment
• Familiarity with international regulatory requirements and knowledge of relevant standards (e.g. ISO 14155, ISO 14971, MedDev 2.7.1 rev 4, EU MDR, applicable MDCG)
• Experience planning and executing internet literature searches using databases such as PubMed
• Experience working with ReadCube, Endnote or other literature repository and citation management tools
• Ability to translate engineering and marketing data into a device performance context
• Demonstrated ability to communicate verbally clearly and effectively and in technical or scientific writing, clear and concise writing style
• Demonstrated ability to apply analytical skills to effectively summarize, communicate, and present clinical trial outcomes
• Demonstrated ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Effective organizational, communication, and project team skills; high attention to detail and accuracy

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).