Endoscopy Program Manager

Role Overview

• 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 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, 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.

Requirements

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

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)