Medtronic Plc
Principal Clinical Evidence Specialist - Pain Intervention - Fridley, MN (Onsite
Medtronic Plc, Minneapolis, Minnesota, United States, 55432
Principal Clinical Evidence Specialist
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. The Principal Clinical Evidence Specialist (Prin CES) is a key leader within the Pain Interventions Evidence Team, serving as the clinical evidence expert for the therapy area. This role is responsible for monitoring and synthesizing scientific literature, developing high-quality clinical and regulatory documents, and effectively communicating complex medical information to internal and external stakeholders, including KOLs. The Prin CES plays a critical role in shaping clinical strategies and leading evidence dissemination efforts, including impactful publications and scientific manuscripts in collaboration with study teams. In addition to driving evidence strategy, the Prin CES partners cross-functionally with Marketing, Regulatory Affairs, Medical Affairs, Reimbursement, Research, and Clinical Study teams. The role also reviews medical and marketing content for scientific accuracy and contributes therapy-specific insights to Clinical Evaluation Reports (CERs). A vital aspect of the role is fostering strong relationships with physicians and investigators to advance published clinical evidence and strengthen the therapy's presence in the scientific and medical communities. Responsibilities may include, but are not limited to: Leads the creation and implementation of publication and evidence dissemination strategies, including writing manuscripts, abstracts, posters, and presentations based on internal clinical research. Collaborates with external physicians and healthcare professionals to co-author content and enhance the visibility of clinical evidence. Maintains a well-organized repository of internal publications and relevant peer-reviewed literature. Contributes to the development of key clinical documents such as Clinical Investigation Plans (CIPs), IDE submissions, and publication plans. Supports investigator meetings, advisory boards, and publication committees to guide evidence generation and strategy. Provides clinical input for Corrective and Preventive Actions (CAPAs) and Field Clinical Actions (FCAs). Ensures claims matrices are current and compliant with clinical evidence and regulatory standards. Drafts and edits scientific reports, comprehensive reviews, and materials for internal and regulatory use. Prepares responses to audit and regulatory queries and ensures readiness for compliance inspections. Offers clinical expertise across cross-functional teams including marketing, health economics, R&D, reimbursement, and regulatory affairs. Conducts clinical reviews of marketing materials to ensure scientific accuracy and compliance. Leads or contributes to gap analyses, evidence strategy development, and the creation of medical evidence reports. Assesses external research proposals for scientific rigor and oversees deliverables to ensure milestone-based compliance. Represents the clinical function on cross-functional teams and in external business collaborations. Communicates effectively with senior internal stakeholders, external partners, and vendors to align on strategic goals. Ensures all work aligns with FDA/ISO regulations, Medtronic policies, and quality system requirements. Location: Fridley, MN (Onsite) Ability to travel up to
Must Have (Minimum Requirements): To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor's degree with at least 7 years of clinical research experience in studies, publications, and/or program management. OR an advanced degree with at least 5 years of experience in studies, publications, or program management. Nice to Have (Preferred Qualifications): 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Medtronic offers a competitive Salary and flexible Benefits Package. 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. Salary ranges for U.S (excl. PR) locations (USD): $131,200.00 - $196,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Learn more about our business, mission, and our commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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. The Principal Clinical Evidence Specialist (Prin CES) is a key leader within the Pain Interventions Evidence Team, serving as the clinical evidence expert for the therapy area. This role is responsible for monitoring and synthesizing scientific literature, developing high-quality clinical and regulatory documents, and effectively communicating complex medical information to internal and external stakeholders, including KOLs. The Prin CES plays a critical role in shaping clinical strategies and leading evidence dissemination efforts, including impactful publications and scientific manuscripts in collaboration with study teams. In addition to driving evidence strategy, the Prin CES partners cross-functionally with Marketing, Regulatory Affairs, Medical Affairs, Reimbursement, Research, and Clinical Study teams. The role also reviews medical and marketing content for scientific accuracy and contributes therapy-specific insights to Clinical Evaluation Reports (CERs). A vital aspect of the role is fostering strong relationships with physicians and investigators to advance published clinical evidence and strengthen the therapy's presence in the scientific and medical communities. Responsibilities may include, but are not limited to: Leads the creation and implementation of publication and evidence dissemination strategies, including writing manuscripts, abstracts, posters, and presentations based on internal clinical research. Collaborates with external physicians and healthcare professionals to co-author content and enhance the visibility of clinical evidence. Maintains a well-organized repository of internal publications and relevant peer-reviewed literature. Contributes to the development of key clinical documents such as Clinical Investigation Plans (CIPs), IDE submissions, and publication plans. Supports investigator meetings, advisory boards, and publication committees to guide evidence generation and strategy. Provides clinical input for Corrective and Preventive Actions (CAPAs) and Field Clinical Actions (FCAs). Ensures claims matrices are current and compliant with clinical evidence and regulatory standards. Drafts and edits scientific reports, comprehensive reviews, and materials for internal and regulatory use. Prepares responses to audit and regulatory queries and ensures readiness for compliance inspections. Offers clinical expertise across cross-functional teams including marketing, health economics, R&D, reimbursement, and regulatory affairs. Conducts clinical reviews of marketing materials to ensure scientific accuracy and compliance. Leads or contributes to gap analyses, evidence strategy development, and the creation of medical evidence reports. Assesses external research proposals for scientific rigor and oversees deliverables to ensure milestone-based compliance. Represents the clinical function on cross-functional teams and in external business collaborations. Communicates effectively with senior internal stakeholders, external partners, and vendors to align on strategic goals. Ensures all work aligns with FDA/ISO regulations, Medtronic policies, and quality system requirements. Location: Fridley, MN (Onsite) Ability to travel up to
Must Have (Minimum Requirements): To be considered for this role, please ensure the minimum requirements are evident on your resume. Bachelor's degree with at least 7 years of clinical research experience in studies, publications, and/or program management. OR an advanced degree with at least 5 years of experience in studies, publications, or program management. Nice to Have (Preferred Qualifications): 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Medtronic offers a competitive Salary and flexible Benefits Package. 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. Salary ranges for U.S (excl. PR) locations (USD): $131,200.00 - $196,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Learn more about our business, mission, and our commitment to diversity. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.