The Senior Clinical Evidence Specialist (Sr. CES) plays 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, authoring new product 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. Responsibilities include leading the creation and implementation of publication and evidence dissemination strategies, collaborating with external physicians and healthcare professionals to co-author content, maintaining a repository of internal publications and peer-reviewed literature, contributing to clinical documents such as Clinical Investigation Plans (CIPs), IDE submissions, and publication plans, supporting investigator meetings, advisory boards, and publication committees, providing clinical input for Corrective and Preventive Actions (CAPAs) and Field Clinical Actions (FCAs), ensuring claims matrices compliance, drafting and editing scientific reports and materials for internal and regulatory use, preparing responses to audit and regulatory queries, offering clinical expertise across cross-functional teams, conducting clinical reviews of marketing materials, leading or contributing to gap analyses and evidence strategy development, assessing external research proposals, representing the clinical function on cross-functional teams and external collaborations, communicating with senior stakeholders and external partners, and ensuring compliance with FDA/ISO regulations and Medtronic policies. Location is onsite in Fridley, MN. Minimum requirements include a Bachelor's degree with at least 4 years of clinical research experience or an advanced degree with at least 2 years of experience in studies, publications, or program management. Preferred qualifications include experience in technical writing, proven record in leading study publications, ability to work within cross-functional teams, familiarity with ICMJE guidelines and Good Publication Practices, knowledge in neurology and/or psychiatry, understanding of clinical research study design and global clinical regulations, ability to manage shifting priorities, provide and respond to feedback, willingness to accept challenging assignments, and strong analytical and critical thinking skills.
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