What you'll be doing:
Legal Counsel will report to the Corporate Counsel, Commercial Affairs and will be responsible for providing legal support of the Company's commercial affairs and operations, including drafting and interpreting company agreements, implementing health care compliance and ethics policies, and advising at various stages of domestic and international product commercialization and marketing.
Who we are:
Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. "In Tandem" means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.
We've have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.
Read more about our company & culture here: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild
What you need for this position:
PRIMARY DUTIES & RESPONSIBILITIES:
Provides legal and business advice and drafting expertise for a broad range of commercial and operational agreements, including confidentiality and non-disclosure agreements, material transfer agreements, supply agreements, manufacturing equipment purchases and leases, distribution agreements, clinical trial agreements, and provider agreements with health insurance payors and administrators.
Delivers advice and training on the requirements of international, federal and state fraud and abuse laws, anti-kickback regulations, physician payment transparency laws, as well as industry codes such as AdvaMed, MedTech Europe, and MEDEC, among others.
Works closely with regulatory, sales and marketing groups to review marketing materials, projects and events.
Provides legal support for the Company's expanding international operations, proactively identify related business and legal risks, and collaborate cross-functionally to offer creative solutions to mitigate risks.
Supports emergent legal matters on an as-needed basis.
Supports continuous improvement of health care compliance program, as well as assists in performing health care compliance training, monitoring and auditing activities.
Drafts and negotiates supply agreements and vendor agreements for critical service providers.
Assists with legal compliance activities, including state compliance reporting, FCPA program administration, and conflict minerals reporting.
Works closely with corporate paralegal and internal clients to develop and improve internal processes that will support the growth of the legal department.
Functions independently and delivers results with minimal supervision.
Maintains the confidentiality of Legal Department communications and documentation.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Other responsibilities as assigned.
Minimum of 5 years of relevant legal experience with complex commercial transactions, including at least 2 years of in-house experience with a medical device, pharmaceutical or biotech company.
In-depth understanding of the federal False Claims Act, Anti-Kickback Statute, and Food Drug and Cosmetic Act.
Working understanding of international, federal and state rules and regulations applicable to medical device companies.
Extensive experience with and breadth of knowledge related to contract law.
Experience negotiating and drafting complex vendor agreements for critical suppliers and service providers.
Working understanding of clinical trials and related laws, regulations and agreements.
Strong verbal and written communication skills.
Ability to operate independently and prioritize effectively while handling substantial and diverse work volume and serving as a key contributor for a rapidly growing organization.
High level of integrity supported by sound judgment and ethics.
Effective interpersonal skills and presentation styles to interact with diverse audiences, including outside attorneys, senior management and business associates.
Expertise in counseling clients on best practices for commercial, compliance, clinical trial and supply chain functions.
Minimum certifications/educational level:
Establishes objectives and work plans and delegates assignments to subordinates. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
What's in it for you?
We've got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care Tandem's got you covered!
Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.
Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.
Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick's Day, costume-contest for Halloween, and the annual JDRF walk.
Tandem Diabetes Care