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Michael Shearn has experience and knowledge in life sciences/healthcare regulatory compliance, business, corporate, and contracting matters. Beginning with a regulatory and securities law practice in the Washington, D.C. office of an international law firm, and subsequently in Texas with two major law firms, he has advised on corporate, securities, acquisitions, partnership, contracting, employment/HR, banking and other issues. He advised, as in-house counsel, two publicly-held biotech companies about regulatory and compliance activities. He served for eight years as Senior Counsel, Compliance & Healthcare, at Genzyme Corporation (San Antonio, TX & Cambridge, MA), focused on compliance with drug, biologics and device product promotional rules, antikickback and false claims laws, and clinical research regulations, including speakers bureaus and fair market value compensation analysis. He joined Genzyme as part of the acquisition of ILEX Oncology in San Antonio, Texas where he was Associate General Counsel for four years. As in-house counsel, including compliance counsel, he created, drafted and implemented policies, guidelines, and training for employees to comply with applicable ethics policies, codes of conduct, and healthcare regulatory laws and rules. In his compliance operational role, Mr. Shearn conducted internal investigations, assisted with monitoring/auditing compliance programs and managed transparency ("sunshine") reporting. He prepared and negotiated, and supervised preparation and management of, distribution agreements, consulting agreements, advisory board agreements, clinical research, and other agreements, including lease agreements.He spoke at national seminars on federal and state pharmaceutical and healthcare compliance matters. He performed contracts and risk management services for a nonprofit laboratory, blood and tissue bank.
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PrincipalMichael Shearn, Jd, Life Sciences/Healthcare Regulatory Compliance Adviser May 2012 - 2018San Antonio, Texas AreaRegulatory compliance advice for life sciences companies and healthcare providers
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Contracts Management & Risk AnalysisBiobridge Global Jun 2014 - Dec 2016 -
Senior Counsel, Compliance & HealthcareGenzyme Corporation Dec 2004 - Apr 2012San Antonio, Texas Area And Cambridge, Ma• Created US corporate standard operating procedure (SOP) for review and approval of nonpromotional scientific, clinical trial or medical information/materials intended for communication to individuals or audiences external to the company that resulted in auditable documentation showing compliance with applicable federal laws and policies• Created global SOP for electronic receipt, review and approval of unsolicited applications by potential investigator-sponsored clinical research grants to be compliant with and auditable under federal laws and rules (OIG, FDA, DOJ)• Drafted and implemented ethics and compliance policies and guidelines, including PhRMA Code, antikickback statute, false claims act, and state transparency ("sunshine") laws, for US drugs and biologics sales and marketing personnel• Developed and presented compliance training for sales and medical affairs personnel • Investigated, monitored, and audited corporate compliance programs to meet annual public reporting requirements and implemented any needed individual corrective action plan• Conducted risk assessments that identified/prioritized compliance risks to focus monitoring/auditing/training plans -
Associate General CounselIlex Oncology, Inc. 2000 - Dec 2004San Antonio, Texas Area• Prepared contractual template provisions to comply with applicable foreign and US legal and regulatory restrictions and rules for compensated international consultants and advisors• Managed corporate contracting processes and negotiated complex contracts, including clinical research agreements and contract research organization service agreements• Advised management and provided employee training on legal, regulatory, and compliance matters, including HR/employment law matters, biologics and drug clinical trial contracts, contract research organization service agreements (ILEX Oncology Services, Inc.), product distribution agreements, SEC and FDA filings, lease negotiations.
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General CounselTexas National Research Laboratory Commission (Supercollider Project) 1990 - 1992Advised Commission and senior staff on legal matters and interactions with US Department of Energy; preparation, negotiation, and review of contracts (construction, property management, procurement, site infrastructure development, research grants, real estate acquisition and conveyance, and lease and property use); management of representation by outside law firms.
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ShareholderCox & Smith Incorporated 1985 - 1990San Antonio, Texas AreaAreas of practice included: business, banking and commercial law; federal and state securities law; corporations; corporate takeover defense; mergers and acquisitions; partnerships; trade secret protection; contracts; promissory notes; deeds of trust, mortgages and security agreements; assignment of rents and leases; Uniform Commercial Code matters; letters of credit; bank corporate trust and indenture trustee matters; international investment; copyright registration; federal/state trademark registration; selected unfair competition and tax matters; legislation.
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ShareholderLaw, Snakard & Gambill, Pc 1981 - 1985Areas of practice included: business, banking and commercial law; federal and state securities law; broker-dealer and investment adviser formation and regulation; securities underwriting and broker placement agreements; Investment Company Act issues; mergers and acquisitions, including asset and real property sale and purchase agreements; corporations; director, officer and shareholder liability; partnerships, joint ventures; bank corporate trust and indenture trustee matters; real property and equipment leases; loan and security agreements; contracts; Uniform Commercial Code issues; letters of credit; international trade and investment; administrative law; selected tax matters, including Foreign Investment in Real Property Tax Act; franchise agreements; legislation.
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AssociateSurrey & Morse (Now Jones Day) 1976 - 1981Washington, D.C.Areas of practice included: federal and state securities law; corporations; partnerships; international investment; Foreign Corrupt Practices Act; federal agency administrative practice, including SEC, FDA, FTC, DOT, ITC, DOD, FEC, Commerce, Treasury and State Departments; antitrust; legislation.
Michael Shearn Skills
Michael Shearn Education Details
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Law School Of The University Of TexasLaw -
Universidad Catolica, Lima, PeruEconomics, History, Spanish -
Special Honors-Plan Ii Liberal Arts Honors Program -
British Institute Of International & Comparative Law, London School Of Economics & Political ScienceEnglish Law
Frequently Asked Questions about Michael Shearn
What is Michael Shearn's role at the current company?
Michael Shearn's current role is Compliance Consultant.
What is Michael Shearn's email address?
Michael Shearn's email address is mi****@****bal.net
What is Michael Shearn's direct phone number?
Michael Shearn's direct phone number is +121073*****
What schools did Michael Shearn attend?
Michael Shearn attended Law School Of The University Of Texas, Universidad Catolica, Lima, Peru, The University Of Texas At Austin, British Institute Of International & Comparative Law, London School Of Economics & Political Science.
What are some of Michael Shearn's interests?
Michael Shearn has interest in Golf.
What skills is Michael Shearn known for?
Michael Shearn has skills like Compliance, Legal Compliance, Medical Compliance, Legal Research, Contract Negotiation, Contract Management, Training, Microsoft Office, Microsoft Word, Powerpoint, Microsoft Excel, Oncology.
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Michael Shearn
Professional Editor, Technical Copywriter; Marketing ConsultantDes Moines Metropolitan Area4yahoo.com, bellsouth.net, hotmail.com, wellsfargo.com1 +151549XXXXX
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Michael Shearn
Human Resources Management At United States Air Force/Recruiting/Pay Roll/Security Manager/Travel Custodian/ Administration Management/Emt/Crossfit CoachTucson, Az -
Michael Shearn
President At Ad Studio, Llc & Realtor At Icon Commercial & Owner At Aspire Media GroupRichmond, Va2tadsarchitects.com, yahoo.com1 +180483XXXXX
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