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Lead Counsel, Head Of Regulatory Compliance, Pharma Services
Refer job# HOMO159357
Lead Counsel, Head of Regulatory Compliance, Pharma Services Duties: Provide leadership and legal advice on a wide-range of legal, regulatory and compliance matters in the pharmaceutical clinical and commercial services space across to the Quality Team, developing an expertise in applicable FDA areas as applicable to the PSG business, including cGMP, GCP, &c. Liaison with Thermo Fisher's Chief Compliance Officer and Key Compliance Leaders (Quality, Quality Audit, EH&S, Finance, Internal Audit, IT, etc.) to provide legal services to support the design, development and implementation of Thermo Fisher's Corporate Compliance Program Provide strategic direction to PSG leadership on FDA (and foreign equivalents) compliance/legal interface Responsible for establishing standards and implementing procedures to ensure that the Thermo Fisher compliance program is implemented across PSG (including anti-bribery, Sunshine Act, SecureMate vendor clearance, &c.). Partner with Corporate Compliance team on all aspects. Lead compliance initiatives (incl. training), communications and cross-functional projects across PSG, acting as liaison with Corporate Compliance as well as developing and implementing core PSG initiatives. Provide legal leadership and oversight for PSG global trade compliance team Work closely with PSG General Counsel, PSG Strategy team and other members of the Corporate Development team as well as with senior and functional leaders of PSG on M&A opportunities. Advise on Company M&A strategy and portfolio objectives, and work on a variety of M&A transactions in all stages, from initial presentations to transaction closings and integration and transition services. From a legal commercial perspective, advise Corporate Development and senior leaders on issues related to due diligence activities, deal structuring, contract negotiations and management of stakeholder expectations. Work closely with Company's functional specialists such as Finance, Tax, IP, HR, Regulatory, EH&S, Risk, etc. and other Company advisors, such as outside legal counsel, audit firms and investment banks, on diligence activities, regulatory filings, closing preparation and integration issues. Drive an environment of continuous process improvement, including initiatives to enhance efficiency, quality and productivity. Management of outside counsel.

Qualifications: JD Degree from an accredited law school and a member in good standing with the Bar. Licensed to practice law in the U.S. 8-15 years target experience. Global life science, health care or highly regulated company or other relevant regulated-sector companies is preferred. A combination of top tier law firm and in house experience preferred. A proven track record of effectively handling complex pharmaceutical regulatory and compliance matters, and large and complex M&A transactions, including international experience for both. Solid experience working with senior management in strategic compliance and M&A initiatives, as well as tactical matters; ability to work well with business leadership and other corporate functions to achieve Compliance and M&A goals of the Company.. Strong negotiation and influencing skills, with a solution oriented mindset. Ability to develop practical processes / approaches to drive solutions to completion. Excellent leadership and management skills, experienced in team building, excellent communication / strong but diplomatic presence, robust and enthusiastic self-starter. Experience working with and managing outside counsel when needed. Exceptional oral and written communication skills.
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