Executive Director & Lead, Global Clinical Development and Global Medical & Scientific Affairs Compliance, Merck Research Labs (MRL) Ethics & Compliance - Merck & Co., Inc. - Upper Gwynedd, PA
(2021-04)
- Lead global team of compliance business partners, advising senior Global Clinical Development, Global Medical and Scientific Affairs, and Outcomes Research leadership by providing solutions-oriented counsel for risk mitigation on the compliance and legal implications of medical affairs practices, compliance issues related to our company-sponsored trials, non-interventional trials, and investigator-initiated studies, navigating novel medical modernization initiatives, and general business proposa
- Collaborate cross-functionally with regulatory and international legal colleagues to provide global compliance support to clinical development, medical affairs, and outcomes research teams to bring consistency and unified approach to teams across markets
- Simplified and improved policies, processes and controls for the clinical development, medical affairs, and outcomes research organization, including leading initiative to revise and standardize division-wide processes for engaging with external consultants
- Closely collaborated with senior leaders to resolve significant & complex situations both discovered and raised throughout organization, including responding to audit findings, remediating internal investigations, and resolving in-market issues at the local level outside the US
- Serve as Compliance Business Lead for company acquisitions, integrations, and research collaboration agreements with experience navigating a variety of acquisitions of various sized targets
- Additional position: Chair of Merck's Global Pro Bono Program in the Offices of the General Counsel (April 2026)
Counsel, Regulatory Legal, Office of General Counsel - Merck & Co., Inc. - Upper Gwynedd, PA
(2019-08 - 2021-09)
- Provided regulatory legal guidance for Company oncology products, including launching one new product and five new indications, and representing Company's legal perspective on associated labeling discussions and preparation and review of promotional materials
- Provided legal review and support for content appearing on Company's corporate webpage
- Advised Market Research team on regulatory legal appropriateness of proposed market research projects
- Provided legal guidance to MRL Informed Consent team to ensure that compliance with laws, regulations, and company policies was maintained in informed consent forms used in Merck's clinical research studies
- Provided legal support to Merck for Mothers and Corporate Responsibility teams
Director & Commercial Compliance Officer, Human Health Ethics & Compliance - Merck & Co., Inc. - Upper Gwynedd, PA
(2015-07 - 2019-08)
- Provided end-to-end commercial compliance support for Oncology Business Unit (November 2017-August 2019) and Hospital Business Unit (July 2015-November 2017)
- Partnered with Office of General Counsel to develop and implement training for commercial field teams on areas including nursing support programs and field reimbursement programs
- Supported all commercial compliance aspects of business collaboration agreement with outside company, including developing and implementing guide for appropriate rules of engagement between companies, working with Office of General Counsel to assess and help the business implement various contractual and antitrust obligations, and providing on-going launch support for combination approvals and indications
- Provided compliance support to US grants team, including analyzing questions related to independence of contribution requests
- Implemented, assigned, and developed additional risk-based monitoring program for Hospital team, including field rides, email review, feedback sessions, and analysis of product information requests
- Led initiative to modify Compliance Field Observation process to model principle of compliance as a business partner
Associate Director, GHH Compliance - Merck & Co., Inc. - Upper Gwynedd, PA
(2015-04 - 2015-07)
- Operated as the Cubist Commercial Compliance Officer during Merck acquisition
- Led Compliance Integration for Cubist into Merck & Co., Inc.
Manager, Global Compliance - Cubist, Inc. - Lexington, MA
(2014-08 - 2015-04)
- Developed and implemented a risk-based field monitoring program and data monitoring parameters
- Coordinated enterprise-wide Compliance training program
- Conducted enterprise-wide mapping and assessment of Cubist committees to determine committee presence and interrelatedness for Cubist Quality Council and executive team
Corporate Legal Intern, Compliance Intern - Cubist, Inc. - Lexington, MA
(2012-06 - 2014-08)
- Researched international fraud and corruption laws and country specific pharmaceutical industry codes to create master country-specific hospitality guidelines and 3rd party anti-corruption questionnaire
- Prepared internal "playbooks" of negotiation terms for employees to use when contracting with clinical research organizations
Legal Intern - Executive Office of Health and Human Services for Massachusetts, Office of the General Counsel - Boston, MA
(2013-03 - 2013-05)
Research Assistant - Boston College Law School, Professor Sanford Katz - Newton, MA
(2011-09 - 2012-05)
Clinical Ethics Intern - UT-MD Anderson Cancer Center - Houston, TX
(2010-09 - 2010-12)
