Legal Director-FDA/Life Sciences Law
Company: Medtronic GmbH
Location: Minneapolis
Posted on: February 25, 2021
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Job Description:
The FDA / Life Sciences Legal Director will have leadership
responsibility for a corporate shared-service team of a lawyer and
senior paralegals with deep substantive expertise in
advertising/promotion law. The Legal Director will be part of the
FDA / Life Sciences team with knowledge and experience of the U.S.
Food and Drug Administration (FDA). The FDA / Life Sciences team
supports corporate functions and Medtronic business and regional
units around the globe. In the Director role, this individual will
work with other team members to provide proactive legal advice and
counsel managing risk on advertising and promotion. In addition,
this individual will keep current and provide subject matter
expertise on innovative legal regulatory approaches for digital
health technologies, and other emerging regulation for artificial
intelligence and machine learning in software as a medical device.
Team members work across business units and geographies resulting
in a unique ability to 1) identify common and conflicting legal
issues and positions and 2) contribute to high-level policy
decision-making. This role requires a high level of responsiveness
to business and functional stakeholders in a large, dynamic and
fast-paced environment. The FDA / Life Sciences Legal Director will
report to the Senior Legal Director of the FDA / Life Sciences
Center of Expertise (COE) team.-- This position could reside in
Minneapolis, MN, Washington D.C., the San Francisco Bay Area, or
alternate location to be discussed. A DAY IN THE LIFE: Lead a team
of a lawyer and paralegals to oversee and review promotional
materials for business Operating Units. Provide deep expertise on
direct-to-consumer advertising, social media, off-label promotion
risk, digital health, and software as a medical device issues to
Operating Units, Compliance and other relevant functions. Provide
strategic direction to COE Senior Director and VP on all issues
regarding advertising and promotion. Lead content development and
counsel on procedures and risk mitigation practices associated with
promotion and advertising. Drive change management and operating
mechanisms for team to provide cost efficient, risk-calibrated
review of Operating Units promotional materials, including product
brochures and Medical Education and training; implement method for
prompt escalation of high-risk issues. Monitor the external
regulatory and enforcement environment to identify risks/trends in
areas of promotion and advertising, digital health, and artificial
intelligence/software as a medical device issues. Manage and
provide leadership for direct reports, including coaching,
development and evaluation of employee performance. Partner with
Medtronic Regulatory Function to provide legal support and
guidance, including developing policies, procedures, legal guidance
documents, tools and training materials related to advertising and
promotion. Provide legal support of compliance investigations for
the Office of Ethics and Compliance involving advertising and
promotion issues. Build and maintain relationships with key
regulators and industry leaders on advertising, promotion and
digital health issues. Provide and work with fellow ELR advertising
experts in supporting a think tank for counseling, training and
providing strategic guidance for Medtronic businesses in FDA
advertising and promotion law. On behalf of the ELR COE, serve as a
strategic Legal partner to one or more Operating Units. MUST
HAVE:
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. 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, Minneapolis , Legal Director-FDA/Life Sciences Law, Legal , Minneapolis, Minnesota
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