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Medical Affairs Program Manager

Company: Medtronic GmbH
Location: Memphis
Posted on: September 13, 2020

Job Description:

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.

The Medical Affairs Program Manager in Clinical Science Strategy is responsible for:

Developing evidence generation strategies across therapies in alignment with Medtronic business needs

Therapy-specific expertise

Manage relationships with R&D, R&T, Marketing, global business partners, and other cross-functional partners to satisfy project needs

A Day in the Life

Drives overall clinical evidence strategy

oDefining clinical evidence needs for current (released product) and new product portfolios

oCollaborates with key internal and external global stakeholders to identify evidence needs

oExecutes a fit-for-purpose strategy to acquire the necessary data to support the desired objectives, including identifying the level of clinical evidence required to satisfy identified business objectives

oLeverages latest literature, regulations and guidance to build and execute on evidence strategies

oLeverages competitive intelligence around regulatory pathways, indications and labeling, claims, clinical and economic evidence to inform and execute on differentiated and market leading evidence that support clinical and economic stakeholders

oAdvocates for appropriate support and funding for highest priority projects, in conjunction with cross-functional evidence team

oCreates overall clinical development plan for products

oProvides input, as appropriate, 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)

Clinical Evidence Strategy team leader for multiple medical device portfolios of products, including procedural solutions:

oCreation of clinical evidence strategy team with cross-functional, cross-BU, and global partners

Works cross-functionally, across regions and business units: Marketing, R&T, R&D, Health Economics, Medical Affairs, Regulatory, External Research Program, Reimbursement (including biostats, legal, and compliance; as appropriate)

oReceive, provide, and track status updates from necessary stakeholders of assigned projects, ensuring alignment

oDrives prioritization of clinical evidence projects within each product/therapy space in conjunction with cross-functional evidence team

oEnsures resources/time spent is in line with project prioritization

Core Team Representative

oHelps determine burden of evidence for our products; e.g., preclinical work, looking at regulatory pathway to come up with an indication expansion, staying up on the latest relevant information

oInvolved in changes to systems/products, and what might be required to support this from a clinical perspective

oKeeps current on over-arching core team project priorities

KOL and Clinician Interactions

oIdentifies and builds meaningful partnerships with key scientific influencers and innovators to understand clinical and economic therapy/market needs from a clinician’s perspective

Additional Responsibilities:

Maintains strong understanding of product knowledge, relevant anatomy, and accepted applications and uses associated with our products

Financial budget modeling and scenario planning around evidence needs

Effective leadership and team facilitation skills to motivate cross-functional and cross-business unit partners to work towards common evidence goals

Assesses project issues and develops resolutions

Develops mechanisms for monitoring project progress for timely intervention and problem solving

Present to, and partner with, clinical and medical affairs leadership and business leaders on the overall health of the portfolio, successes, and areas of opportunity

Maintains awareness and understanding of the market and competitive space

Must Have: Minimum Requirements

Bachelors degree required

Minimum of 5 years experience in clinical science strategy

Or an advanced degree with a minimum of 3 years experience in clinical science strategy

Nice to Have

Degree in engineering, life sciences, or related medical/scientific field

Clinical Research experience at Medtronic or within a medical device industry

Experience working on a Global team

Basic understanding of biostatistics and trial design

Proficient knowledge of medical terminology

Determine the level of clinical evidence required based on the outputs needed by the business

Excellent project management and organizational skills

Ability to motivate and drive accountability among cross-functional team members

Ability to communicate complex information in a clear, concise manner

Proven ability to cultivate an active network of relationships within and outside of the organization

Thrives in a dynamic environment

Willingness to adapt to changing priorities

Proficient experience using Microsoft Word, Power Point, and Excel

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

Create and manage profiles for future opportunities.

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Memphis , Medical Affairs Program Manager, Other , Memphis, Tennessee

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