Endoscopy CRMS Program Mgr

Medtronic•Lafayette, CO

15d

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 The Endoscopy operating unit improves patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies. We develop diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers. As an Endoscopy Clinical Research Program Manager, you will have primary responsibility of managing the integrated clinical and medical science strategy for the Capsule Endoscopy portfolio. You will participate in new product development, lead clinical evidence generation and dissemination and collaborate across the organization to drive market adoption for multiple innovations across the portfolio. This position should be able to function with minimal supervision. Location: Prefer candidate to be in Lafayette, CO or Mounds View, MN.

Requirements

Bachelor’s degree required
Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

Nice To Haves

Experience creating Clinical Studies.
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

Provide subject matter expertise to guide evidence-based targeting of the appropriate patient population, clinician, and disease state for MDT therapies.
Strategically influences potential product development and product roadmaps through providing medical / scientific input.
Develops, implements, and oversees integrated CRMS strategy (in partnership with Medical Science, Medical Education, Health Economics, and Clinical Research functions) for assigned product portfolios aligned with the strategic goals of the business to enable market access and product adoption.
May be involved in early clinical study development and statistical planning.
Provides scientific input for evidence generation including sponsored research, ERPs, Scientific Services, Collaborative Research and Alternative Data Source projects
Utilizes advanced subject matter expertise to provide medical / scientific input to various functions to facilitate insightful decision-making and enable achievement of business objectives
Serves as point of contact, subject matter expert, and liaison for Global and Regional level cross functional groups
Uses program management and influence skills with cross-functional partners to work towards common goals and drive execution of the CRMS strategy
Provides input into clinical evidence documents to ensure alignment with overall business strategy, including Protocols, Clinical Study Reports, EUMDR documentation (such as the Post-Market Clinical Follow-Up Plans [PMCF]), External Research Proposals (ERPs)
Tracks and leverages latest literature, regulations, clinical trends, and guidance to inform evidence strategies
Collaborates with key internal and external global/regional stakeholders to develop medical evidence reports, lead cross-functional gap analyses, determine geographic evidence prioritizations, and create future evidence strategy proposals
Creates, reviews and provides input on content, including internal and external medical education materials, key product messages and claims, promotional materials, new or existing literature and collateral, ensuring scientific validity and accuracy
Packages and disseminates medical and scientific information for both internal and external clients stakeholders
Provides evidence trainings and updates to the field team
Understands and effectively communicates current published medical / scientific knowledge.
Compiles, analyzes, and summarizes data from a variety of sources as needed, and synthesizes complex data and information into succinct messages.
Collaborates with R&D and Regulatory Affairs to review and approve device risk file documentation and provides medical / scientific expertise during interactions with regulatory bodies.
Conducts scientific literature review for regulatory compliance purposes.
Supports creation and maintenance of claim matrices to ensure accuracy and alignment with current evidence base.

Benefits

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.
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)