Job Information
Medtronic Senior Medical Affairs Specialist in Louisville, Colorado
Senior Medical Affairs Specialist
Location:
Memphis, Tennessee, United States
Requisition #:
20000DL1
Post Date:
Oct 27, 2020
SENIOR MEDICAL AFFAIRS SPECIALIST
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Within RTG, the Cranial Spinal Technologies division offers an integrated portfolio of devices and therapies for the treatment of neurological, cranial, and spinal disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neurological, cranial and spinal procedures.
Careers That Change Lives
The Senior Medical Affairs Specialist in Clinical Science Strategy is responsible for:
Supporting the development of evidence generation strategies across therapies in alignment with Medtronic business needs
Therapy-specific expertise
Manage relationships with RD, RT, 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
oHelps to create overall clinical development plan for products
oProvides 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)
- Clinical Evidence team leader for medical device portfolio of products:
oCreation of clinical evidence team with cross-functional, cross-BU, and global partners
- Works cross-functionally, across regions and business units: Marketing, RT, RD, 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
- Clinical Evidence support team member for Medical Affairs Program Managers
oProvides support to other Clinical Evidence teams as needed
- 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
Prepares status reports
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
To be considered for this role, the minimum requirements must be evident on your resume.
Bachelors degree required
Minimum of 4 years of clinical marketing, clinical research or applied research experience
Or advanced degree with a minimum of 2 years of clinical marketing, clinical research or applied researchexperience
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
Determine the level of clinical evidence required based on the outputs needed by the business
Excellent project management and organizational skills
Takes initiative and demonstrates a high level of independence
Proficient knowledge of medical terminology
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)
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.
