Senior Clinical Evidence Specialist - NM - Rice Creek, MN

Medtronic•Fridley, MN

7d•Onsite

About The Position

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life. As Senior Clinical Evidence Specialist (CES), you will play a key role within the Pain Interventions evidence team. This role involves literature review, medical evidence gap analysis, publication planning, writing manuscripts, facilitating publication committees, reviewing marketing materials, providing SME for Clinical Evaluation Reports (CERs) and evaluating physician-sponsored studies. Additionally, the CES will collaborate with cross-functional teams, including marketing, medical affairs, reimbursement, research, and study teams, and may serve as a clinical representative on core teams.

Requirements

Bachelor's degree with minimum of 4 years of clinical research experience in studies, publications, and/or program management.
OR an advanced degree with minimum of 2 years of experience in studies, publications, or program management.

Nice To Haves

Experience in technical writing including clinical study plans, clinical reports, scientific manuscripts, clinical evidence reports.
Proven record in leading study publications including authorship.
Demonstrated ability in working within a matrix of cross functional stakeholders including project management skills and experience with related tools
Familiarity with ICMJE guidelines and Good Publication Practices
Knowledge in the areas of neurology and/or psychiatry
Understanding of clinical research study design, Good Clinical Practices, and global clinical regulations (e.g., FDA, ICH guidelines) for medical devices, biologics, and/or pharmaceuticals.
Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
Ability to provide performance feedback and to appropriately respond to feedback from customers and coworkers
Willingness to accept challenging assignments and engage in professional developmental activities
Strong analytical and critical thinking skills with the ability to identify and resolve issues efficiently.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Create and submit manuscripts based on clinical studies and/or scientific reports.
Create and submit abstracts, poster presentations, podium presentations.
Engagement with external physicians/HCP(s) on publications, scientific communications and evidence dissemination.
Conduct Literature reviews, summarize scientific findings, develop medical evidence reports, and lead cross-functional evidence gap-analysis.
Contribute to publication planning and evidence strategy development.
Support study Investigator meetings and/or Advisory Boards.
Maintain a database of peer-reviewed literature and internal publications.
Create responses for audit/submission queries.
Reports instances of complaints/adverse events from literature to Global Clinical Health (GCH).
Write and edit manuscripts, comprehensive reviews, and scientific reports for regulatory submissions and internal use.
Provide clinical expertise and collaborate with cross-functional teams, including marketing, health economics, reimbursement, research & development, and regulatory affairs.
Conduct clinical review of marketing materials
May facilitate Publication Committees and Plans in collaboration with Physician Investigators to ensure accurate high impact publications.
May work internally to obtain input on Publication Plans with updates regularly to address evidence gaps.
May work with investigators to resolve problems quickly and effectively.
May serve on cross-functional core teams as the clinical representative
May work on business collaborations with external partners
May develop medical evidence reports, lead cross-functional gap analysis, and propose future strategy.
May update and communicate medical evidence assessment and gap analysis.
Prepares evidence-based material for new products and revises existing materials.
May evaluate external research proposals for scientific soundness.
May ensure compliance with milestone-based payment through receipt of reports and approved deliverables.
Communicate with senior internal and external customers and vendors
Ensure adherence to FDA/ISO, Medtronic policies and all work/quality procedures to ensure quality system compliance and high-quality work.

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)