- Provide legal counsel to Abbott's Electrophysiology team on compliance, risk management, and other legal issues in the context of federal and state regulatory requirements, including those relevant to sales and marketing of products to health care professionals and reimbursement by government programs areas, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act).
- Possess strong knowledge of corporate and commercial/transactional law and demonstrated expertise in drafting and negotiating complex commercial agreements and advising and counseling clients on a range of business transactions and operational matters.
- Participate in the drafting, negotiating, and reviewing a wide range of agreements, including major commercial contracts and complex agreements with suppliers, researchers, hospitals, GPOs, governmental entities, and health care professionals.
- Facilitate the business objectives of Abbott by providing practical, timely, and effective legal support, while minimizing potential legal risks.
- Supervise and direct outside counsel as needed.
- Work in close cooperation with compliance organization to coordinate and streamline efforts.
- Identify training needs and assist in development and presentation of training and education regarding legal requirements and developments.
- Develop a thorough understanding of and familiarity with Abbott's businesses, its people, products, markets, facilities, customers, and competitors, and use this knowledge in providing guidance and counsel to the Electrophysiology team.
- Possess a Juris Doctor degree from an accredited law school, demonstrate a strong academic background, and be admitted to a US state bar in good standing.
- 7 years minimum, prefer 8+ years of experience as a commercial attorney at a top law firm and/or in-house.
- Ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment.
- Strong process and analytical skills.
- Excellent problem-solving ability.
- Excellent time management skills and ability to manage competing priorities while ensuring timely completion and follow-up.
- Ability to independently handle complex matters with minimal supervision and understand which issues to elevate to senior management and appropriate timing for doing so.
- In addition to top-notch legal skills and a strong ethical center, excellent interpersonal, strategic thinking, communication, and organizational skills.
- Experience representing an FDA regulated company, including knowledge of corporate law, fraud and abuse laws, Anti-Kickback law, Sunshine Law, AdvaMed Code, HIPAA, and other laws and regulations pertaining to the pharmaceutical or medical device industry.
- Medical device, pharmaceutical or other health care business experience, and/or hospital/health system experience.
- Demonstrated ability to understand and comply with applicable FDA regulations and company operating procedures, processes, policies, and tasks.
- Proven ability to lead attorneys and/or paralegals, and to perform successfully in cross-functional teams, with the ability to lead and mentor.
- Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
- In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
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Senior Counsel – Commercial, Electrophysiology - Plymouth, United States - Abbott
Description
The Opportunity
This position works out of our Minneapolis, MN or Austin, TX location in the Electrophysiology Division.
Abbott is currently seeking an experienced commercial attorney to provide legal advice to Abbott's Electrophysiology Division. As a member of the team, the attorney will provide legal guidance to Abbott's Electrophysiology business unit across a variety of areas, including research & development, supply chain, clinical, regulatory, quality, marketing, and sales.
What You'll Work On
This position will interact with the Legal, Compliance, Finance, Education, Supply Chain, Research & Development, Regulatory, Quality, Clinical, Marketing, Sales, and Information Technology Departments.
Required Qualifications
Preferred Qualifications
Divisional Information