Senior Counsel

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minnesota and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.

With projected revenue to be over $1 Billion by 2012, our fastest growing division, Atrial Fibrillation Division (AFD), is committed to hiring world class talent that will continue to drive us to lead the way in the treatment and cure for atrial fibrillation.  St. Jude Medical is the only medical device company to dedicate a business unit solely to diagnosing, treating and curing atrial fibrillation, the world's most common cardiac arrhythmia. For more information, please visit .

Senior Counsel

We are seeking a high caliber leader for the Senior Counsel role in our Atrial Fibrillation division (AFD). The SC will serve as a primary legal advisor for AFD and will be a key member of the legal team. The SC reports directly to the General Counsel.

The SC provides direct legal counsel/guidance in the regular/special activities of AFD to ensure maximum protection of the legal rights of the company and to maintain its operations within the limits prescribed by law.  The SC participates in the preparation and negotiation of contracts, and prepares other related reports and statements of a legal nature. Additionally, the SC assists in solving and resolving regulatory and/or contractual problems and issues encountered by senior management. 

Impacts this role will have:

• Advise all business units on a wide range of legal issues including federal and state anti-kickback statutes, False Claims Act and whistleblower statutes, other fraud and abuse provisions, and FDA marketing and labeling restrictions. 


• Leads initiative to develop division-wide compliance programs, policies and training.  Track and comply with state law requirements and federal health care reform legislation.  Conduct compliance training throughout the business.


• Manage all legal and compliance issues concerning national and international clinical trials, including drafting and negotiating clinical trial and financial agreements for large multi-center investigational device and post-market clinical trials. 


• Draft and negotiate research grants and sponsored research agreements for pre-clinical and clinical studies with national and international physicians and research institutions. 


• Counsel the division’s Study Review Team, which reviews physician initiated research proposals and grant requests on fraud and abuse implications, FDA restrictions and grants and contract issues. 


• Review all marketing materials and publications to be distributed along with trade show materials, for compliance with FDA and other laws and regulations, as well as proper trademark usage. 


• Draft and negotiate a wide variety of complex commercial agreements.


• Manage litigation and pre-complaint investigations involving the division on a wide range of issues, including various employment matters.

• Supervise paralegal and administrative staff on contract management issues.  Work across other SJM divisions, and within the division, to establish effective contract management techniques.


• Oversee multiple outside counsel, contract attorneys and a paralegal on a wide range of pre-litigation, litigation, regulatory and transactional matters. 

Qualifications:

• Juris doctorate required, prefer Bachelor’s degree in Business, Engineering or Science.


• Eligibility for admission to the Minnesota Bar is a requirement.


• Minimum of seven years post law school experience with progressively more responsible work experience in corporate law, including: corporate and transactional experience, regulatory compliance counseling, and litigation experience; and, the ability to understand complex biomedical devices. 


• Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills.


• The ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. 


• Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. 

• Applied legal experience in the medical devices, biomedical, pharmaceutical or related industries.

Preferred Qualifications:

• Membership in the Minnesota Bar Association and other legal associations; with sub-memberships in

Corporate law and/or food and drug law.

• Bachelor’s or master’s degree in business, science or engineering.

To learn more, visit our web site at .  St. Jude Medical is an equal opportunity employer.