Senior Clinical Evidence Specialist - Fridley, MN (onsite) or Remote within US

We anticipate the application window for this opening will close on - 21 Feb 2025

 

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 LifeThe Senior Clinical Evidence Specialist (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 may include the following and other duties may be assigned.

• 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).

A Day in the Life

• 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 to milestone-based payment through receipt of reports and approved deliverables.

• Communicates 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.

Minimum requirements:

To be considered for this role, the minimum requirements must be 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.

Benefits & Compensation
 

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):$103,200 - $154,800

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:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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 here 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.

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