Primarily supporting strategic and operational pull-through for all commercial functions in the marketing and commercialization of company’s approved and pipeline products. How do I do that? It’s all about building strong trusted relationships and being a thoughtful business partner to sales, market access, patient support services, marketing, channel and trade.There’s also a lot of materials and contracts to review.

Served as a dedicated business and regulatory attorney focused on serving the legal needs of the healthcare, life science, and biotech industries.Provided practical and thoughtful advice to help start-ups and established businesses navigate the special rules related to reimbursement, compliance and marketing of their therapies, healthcare products and services.Main practice areas included:- Pharmaceutical and medical device development and commercialization strategies and regulatory approvals.- Innovative manufacturing and clinical trial programs.- Market access issues including drug pricing, rebate and payor agreements, supply and distribution channels, patient assistance programs, and product HUBs- Compliance programs, auditing and monitoring.

Delivered legal guidance and advice related to new development of health plan and provider payment integrity solutions.Drafted / reviewed / negotiated agreements related to new solution development (e.g., vendor, licensing, confidentiality, master service, proof of concept, software license, data use and privacy agreements). Provided advice on the feasibility of, and lead negotiations of sophisticated agreements related to, business growth opportunities.Counseled business on compliance programs and policies pertaining to healthcare and other regulations (e.g., Fraud and Abuse issues, HIPAA, and Consumer Privacy).Researched health plan reimbursement laws and regulations related Medicare, Medicaid, Commercial, and managed care companies.

Advised business clients on the regulatory challenges facing pharmaceutical drug businesses. Provided guidance, legal advice, and practical solutions on a wide range of regulatory matters that relate to the delivery of health care and development and marketing of pharmaceutical products. Relevant contributions included:- Drafting / reviewing / negotiating pharmaceutical and biotechnology related and general commercial contracts (e.g., vendor, licensing, confidentiality, master service, clinical trial, clinical supply, technical or lab services, software license, safety data exchange, consulting, R&D, manufacturing, indemnity, and managed care). - Negotiating sophisticated reimbursement agreements, including value-based arrangements, related to branded retail and specialty pharmaceutical products.

Promoted to provide legal leadership on complex issues and high profile risk areas for regulatory compliance and commercial transactions. Partnered internally with Sales, Medical Affairs, Payor Contracting, Distribution, Finance, Tax, Compliance, and Marketing; interfaced with regulatory bodies, outside counsel, outside vendors, and payors.- Developed six-month Center of Excellence training program related to FDA's drug advertising and promotional requirements for new product development, approval, and launch. Trained three new-to-industry attorneys and other internal departments.- Brought managed care contracts in house and enhanced templates to streamline reviews by 50%. Created consistent minimum contracting standards and definitions to achieve 70% acceptance of standard clauses.- Drafted and negotiated agreements that established network of six specialty pharmacies and four specialty distributors for new cold chain, controlled substance product.- Developed communication guidelines for implementing FDA industry advice on evidentiary standards related to product claims. Helped regain state Medicaid formulary access in three states, restoring 100% state Medicaid coverage.- Advised Compliance on policies and procedures to mitigate legal and regulatory risk areas such as Physician contracting and remuneration statutes / regulations, PhRMA code and ACCME guidance, and Patient privacy statutes and regulations including HIPAA (and state equivalents).- Appointed by company Executive Committee as departmental culture champion in recognition of excellence in team-mindedness and display of strong cultural competencies.

Served as counsel for Global and North American medical affairs and private / public reimbursement finance. Acted as primary legal reviewer for medical education materials to support pipeline product development, investigator initiated research agreements, and educational grants.- Provided legal advice on matters related to managed markets and payor contracting, patient support and assistance programs, and distribution and supply channels.- Drafted, reviewed, and negotiated ~200 business and service contracts per month, e.g., master service agreements, consulting agreements, and managed Medicaid / Medicare rebate agreements.- Monitored relevant legal updates in pharmaceutical industry. Advised business of potential impact on strategic objectives and delivered compliance training to sales and commercial departments.

Drafted, reviewed, and negotiated global function contracts (~3000 / year) including master services, clinical trial, and professional consulting agreements; equipment and real estate leases; and statements of work. - Also handled contracts for global functions (Finance, HR, IT, Legal, Medical) as well as R&D and Supply Chain (product pipeline development and manufacturing).- Initiated and managed process improvement initiatives to fully deploy capabilities of enterprise-wide contract management solution. Reduced contract review turnaround time by 60%; refined contract templates to reflect most common edits; and enhanced transparency, which improved internal business partners' satisfaction.

Focused on health care regulatory compliance issues, including state health care licensure and enforcement, Medicare / Medicaid enrollment, reimbursement and third-party payor disputes, advice, and appeals, and Certification matters such as compliance with Medicare Conditions of Participation.- Counseled on matters related to fraud and abuse (Stark and Anti-Kickback Laws, civil monetary penalties), physician payment issues, and fair market value assessments. - Advised on general corporate matters such as entity creation and business operations / policy development.- Provided support and counsel for M&A due diligence (e.g., management of electronic document review system and regulatory compliance on acquisitions that ranged from small to large multi state multi-specialty physician practice and health system mergers)- Served as a seconded member of corporate compliance committees and assisted with development of policies and tools for annual compliance work planning and corrective action plans.

Served as creditor's rights bankruptcy attorney. Drafted extensive motions and supported senior attorneys during bankruptcy adversarial proceedings. Served as first and second chair during state evictions and small claims creditor's litigation.

Summer clerk at the Office of Hearings

Medical malpractice defense summer associate.