Providing general legal support to a variety of global internal clients: Clinical Science & Medical Affairs, Health, Safety & Environment; Charitable Giving (Grants & Donations, Trade Show support); Professional Affairs (HCP Consulting Contracting); Regulatory, US State LicensingReviewing, Drafting, Advising and Negotiating a variety of agreements including company sponsored clinical study agreements, investigator initiated clinical study agreements, data capture agreements, master services agreements, HCP consulting agreements, grants & donations, as well as other agreement types as required.

Providing legal support to global facility management team. Advising on health, safety and environmental matters, including compliance with OSHA, EPA initiatives, pandemic awareness and response. Advising on various US and international commercial transactions, including drafting and negotiating sales, clinical studies, medical education, non-disclosure, grants, donations, equipment loan, equipment evaluation, supplier, and service agreements. Supporting international marketing initiatives through the review of promotional, sales, and educational materials, policy drafting, and advising on various legal matters involving privacy, intellectual property, and compliance with relevant laws, rules, regulations, and industry codes.

Providing legal support to commercial business in Asia Pacific and Emerging Markets. Drafting commercial agreements across multiple categories, including professional services, license and distribution, clinical trials, sales, supplier, information technology, recruiting, settlement, branding, and medical education agreements. Advising business on compliance with global and local policies, rules, laws and regulations governing subjects including data privacy, anti-spam, intellectual property, marketing compliance, interactions with healthcare professionals, and IT systems. Drafting policies and providing training to align business with best practices and relevant rules, laws and regulations.

Responsible for the review of promotional material and advertising literature for all US and international businesses, including Wound Care, Endoscopy, Orthopaedics, Trauma, Gynecology, and Advanced Healing. Advise on the proper completion of marketing materials, advertisements, sales campaigns, surgeon education, scientific literature, and promotional conduct. Advise on intellectual property, compliance, privacy, FDA, FTC, and other matters. Responsible for the completion and negotiation of procurement and scientific research agreements for the US Sports Medicine business. Provide training for personnel on areas of responsibility and contribute to company policies and procedures. Legal representative on the company committee on Social Media and reserve voting member on the Advanced Surgical Devices Division’s Compliance Review Board and Grant Review Board.

Providing support for Mexican business via healthcare professional interaction review and approval. Responsible for preparation and implementation of policies and procedures to align Mexican offices with corporate compliance policies and mandates. Training on policies and systems, visiting distributors and integrators to communicate corporate compliance messages and set expectations. Constructing and implementing CAPAs, and discussing relevant business concerns and tailoring policies and programs as necessary and in accordance with Mexican law.

Advising personnel to ensure compliance with corporate policy, State, Federal and International law, including adherence to the Anti Kickback Act, False Claims Act, Foreign Corrupt Practices Act, state reporting requirements, UK Bribery Act, French and Belgian reporting laws, Advamed and Eucomed codes of conduct and other relevant laws and codes. Managing the Sports Medicine division’s contracts with Health Care Professionals, including conducting weekly meetings to review submissions for adherence to compliance policies, proper execution, and payment. Monitoring compliance systems, aiding in the development and expansion of systems, and training domestic and international personnel. Reviewing and drafting compliance policies. Drafting agreements in conjunction with the General Counsel. Providing compliance support for New Business Development opportunities. Managing budgets and working with personnel to resolve issues.