Deputy General Counsel, Clinical Research & FDA Regulatory - Minnetonka, MN

Minnetonka, MN

Posted 35 months ago

Position No Longer Available

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Position No Longer Available

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Job Description

Bring us your experience, your head for strategy, your strength with relationships and your eye for opportunity. In return we offer an unmatched place to grow and develop your career among a richly diverse group of businesses driven by the power and stability of a leading health care organization. Come help us heal and strengthen the health care system as you do **your life's best work.(sm)** Optum Labs, part of UnitedHealth Group, is focused on research and innovation to help solve health care's greatest challenges. As part of the Optum Labs legal, compliance and regulatory team, this position will serve as legal counsel supporting clinical research, medical device, digital health, and innovation programs. The successful candidate will work in a team-oriented, results-driven group that focuses on issues at the intersection of law, technology, and healthcare. **Primary Responsibilities:** + Serve as primary legal counsel for clinical research initiatives, including clinical and pragmatic trials for investigative devices and new drugs + Provide counsel on issues related to the US Food, Drug and Cosmetic Act, medical device regulations and policies, including those relating to recalls, promotion and advertising, clinical studies, medical device reporting, corrections and removals, product approvals, inspections, and FDA's quality system regulations + Provide legal oversight for the quality management system and related activities + Act as a strategic partner to executive leadership and researchers on legal and compliance issues related to FDA law, regulation and policy and related government policy and enforcement + Partner with the compliance and regulatory affairs teams to assist and counsel in developing policies, procedures, product manuals, legal guidance documents, and tools and training materials; legal support for compliance investigations involving FDA issues + Monitor the regulatory and enforcement environment to identify risks; perform day-to-day counseling and training of functional teams; update business stakeholders on relevant regulatory developments + Partner with product and communications teams on relevant marketing and promotional matters + Provide legal support in obtaining the FDA clearances and approvals; provide legal support related to compliance with FDA post-market requirements + Manage outside counsel You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. **Required Qualifications:** + Juris doctorate degree; current admission to a U.S. state bar, and admission to the Minnesota bar within one year of accepting offer of employment + 10+ years of relevant experience, including direct experience with clinical research programs, FDA medical device regulations, investigational device exemptions, institutional review boards, and FDA marketing / advertising / promotion regulations + Ability to manage, handle, and prioritize multiple projects + Ability to effectively advocate / problem-solve as necessary to obtain desired outcomes and meet regulatory requirements + Ability to work collaboratively in a team setting with other attorneys, clinical, and scientific personnel at multiple levels; ability to work in a matrixed environment + Well-developed written and verbal communication skills + Poise and confidence necessary to deal with senior lawyers and business leaders + Ability to identify issues and offer proactive, timely advice and follow through to resolution + You will be asked to perform this role in an office setting or other company location. + Employees are required to screen for symptoms using the ProtectWell mobile app, Interactive Voice Response (i.e., entering your symptoms via phone system) or a similar UnitedHealth Group-approved symptom screener prior to entering the work site each day, in order to keep our work sites safe. Employees must comply with any state and local masking orders. In addition, when in a UnitedHealth Group building, employees are expected to wear a mask in areas where physical distancing cannot be attained. **Preferred Qualifications:** + 15+ years of relevant experience, including in-house and private practice or government experience + 3+ years of experience managing teams + Additional expertise in FDA pharmaceutical regulation + Additional experience supporting clinical laboratories; experience with CLIA regulations Optum Labs brings together experts in the fields of research science, clinical research, data analytics and technology to solve health care's greatest challenges and achieve our mission of preventing, detecting, and intercepting disease. Our work is enhanced through substantive engagement with partners, including academic, clinical, and policy leaders from across health care, working together to create a health care system that is personalized, convenient, and affordable for everyone. _Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law._ _UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment._ Job keywords: Minnetonka, Minnesota, MN, 908967

Position No Longer Available

Job Summary

Company

UnitedHealth Group

Start Date

As soon as possible

Employment Term and Type

Regular, Full Time

Required Education

Doctorate

Required Experience

10+ years