Instrumentation Laboratory - Bedford Corporate and Compliance Counsel in Bedford, Massachusetts
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
The Corporate and Compliance Counsel work will focus primarily in two areas: (1) drafting, negotiating, and providing legal advice relating to a broad range of the Company's commercial contracts, and (2) leading compliance initiatives related to the Medicare/Medicaid Anti-Kickback statute in connection with the Company's Compliance Program. This is a unique opportunity to work on a broad range of legal matters with key Company stakeholders, including with senior management. The attorney will report to another attorney on the team, with their compliance related work supervised by another team attorney. This role will serve as a trusted advisor and business partner.
Draft and negotiate a broad range of the Company’s routine and strategic transaction agreements across multiple departments, including but not limited to:
Clinical Trial Agreements
Development and License Agreements
Advise senior company leadership on contractual matters, including the interpretation and implication of material contract terms, such as termination rights, liability limitations, indemnification obligations, protection of intellectual property, regulatory requirements, etc.
Support the Company’s North American Sales organization in the negotiation of commercial agreements including, without limitation:
Master Supply Agreements
Reagent Rental Agreements
Support other strategic transactions and corporate initiatives as the need arises.
Support the Company’s corporate compliance program, particularly as it relates to the North American Marketing and Sales organizations’ compliance with the Medicare/Medicaid Anti-Kickback Statute, as well as HIPAA.
Execute compliance initiatives and provide advice and training to internal client groups on corporate policies, laws and regulations.
Draft and review compliance-related materials including policies, procedures, communications, and awareness materials that support the compliance program.
Proactively interact with employees, suppliers and other third parties to communicate IL’s compliance-related obligations and respond to compliance and ethics inquiries, both externally and internally.
Stay abreast of compliance trends and best practices.
Support other strategic compliance initiatives as needed, including in the areas of data privacy, export control, sanctions, and anti-corruption.
Closely align with other members of the Legal Department to provide consistent advice across the Company when evaluating legal issues and recommending how best to mitigate perceived risks.
Frequently engage with senior Company leadership on potential contractual and compliance issues with minimal oversight and guidance from Department attorneys.
Internal Networking/Key Relationships
To be determined based on department needs, to include interactions such as:
Advise Senior North American Sales team leadership on contract terms and compliance related matters.
Present compliance matters and initiatives to Senior Company management.
Work with Senior members of the Quality, R&D and Operations departments on contracts, including representing the Company in contract negotiations for these departments.
Work with Werfen Senior Leadership, including the Chief Compliance Officer and the Legal Director, on compliance initiatives and matters.
Work directly with the General Counsel to support strategic transactions and corporate initiatives.
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
Enthusiasm to work on a broad variety of legal matters.
Strong team player who is both committed and flexible.
Ability to form and maintain collaborative relationships with internal clients while maintaining firm adherence to department standards.
Excellent negotiation, drafting, communication, problem solving, business judgment and strategic thinking skills.
Ability to take ownership of work but seek guidance when needed.
Ability to work independently with excellent administrative, computer and time management skills.
Minimum Knowledge & Experience required for the position:
J.D. degree or equivalent from an accredited law school
Admitted to or qualified for admission to the bar in a jurisdiction within the U.S.
4 to 7 years of relevant corporate and/or compliance experience in a leading law firm and/or a healthcare/life sciences company. Law firm combined with in-house experience is preferred.
Substantial experience independently drafting and negotiating transaction agreements.
Demonstrated experience working with global corporate compliance programs.
Familiarity with federal Medicare/Medicaid Anti-Kickback and Sunshine Act statutes and their associated rules and regulations, including those pertaining to commercial contracts, discount and service arrangements and engagements with healthcare professionals.
Additional Beneficial Skills/Knowledge:
Experience with FDA rules and regulations pertaining to medical devices is considered a plus.
Experience with anti-bribery and corruption laws and regulations, including the Foreign Corrupt Practices Act is considered a plus.
Experience with sanctions and export control compliance matters is considered a plus
Experience with data privacy, particularly in the HIPAA context, is considered a plus.
Experience with employment litigation is considered a plus.
- Required: Yes
- <5% of time
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
Job ID: 2021-4670
External Company URL: https://werfen.com/en
Street: 180 Hartwell Road