Healthcare Executive and Corporate Advisor : Direct innovative strategies in medical affairs, external funding, patient advocacy, compliance, risk management and governance. Establish new paradigms for strategic medical and clinical functions to gain efficiencies, optimize cost, ensure compliance, uphold operational excellence. Direct healthcare compliance assessments, lead implementation of programs mitigating impact of Corporate Integrity Agreement (CIA) obligations in Medical and R&D.

Director in Risk & Regulatory, Maureen specialized in working with clients in the pharmaceutical and medical device industries. Lead engagements covering CIA readiness, Medical/R&D Risk and Compliance Assessments, Medical Affairs organizations/ strategy development in order to effectively address new challenges and an evolving business model. Led multiple Compliance Readiness and Gap Assessments for Corporate, Clinical and Medical Affairs functions including Research (Sponsored and non Sponsored Research), Publications, Clinical and Regulatory Disclosure, Independent Medical Education, Health Care Charitables, Sponsorships and other types of External Funding including Patient Assistance Programs. Defined and implemented mitigation strategies, prioritization plans & organizational recommendations to mitigate risks and compliance gaps.Proactive regulatory and compliance trend analysis: early detection of increased scrutiny by HHS Office of Inspector General into activities in respect to Independent Charity Patient Assistance Programs. Headed assessments for clients to define compliance, organization and operational risks, recommending and implementing mitigation strategies.Co-lead of redesign of biopharma independent Foundation including review/revision of Articles, Bylaws, Foundation Organization including board, officers and advisory council, SOP, training, Conflict of Interest Policy and the review of Foundation go forward strategy.Strategic prioritization for the initiation of a new Medical Affairs Organization in Medical Device company transitioning to a focus on biomedical device/pharmaceutical combinations. Incorporated a risk assessment /inventory, required compliance procedures and controls, organization model and a 2 year actionable road map.

Executive Director – accountable for Publications Management, Collaborative Research, Investigator Initiated Research, Independent Medical Education, Healthcare Charitable Donations and Japan Medical Grant Management - 70 FTE's US, UK, Japan and China. Translated and executed CIA obligations, Transparency and Disclosure, Publication Management, Independent Medical Education (CME/CPD) & Healthcare Charitables. Directed implementation of key monitoring strategies as per Regulatory Authorities, FCPA, CIA obligations, Federal and State requirementsTransformed external funding models in Independent Medical Education and Investigator Initiated Research delivering cost efficiencies while retaining regulatory& operational excellence. Member Clinical Trial Policies Steering Committee, defining strategy, development, implementation, internal communication of those policies. The polices included:PhRMA Principles on Conduct of Clinical Trials & Communication of Clinical Trial Results & associated 5 publically disclosed Clinical Trial policies including Expanded Access/Compassionate use of unapproved investigational product, Public Disclosure and Authorship Led cross divisional teams in Pfizer’s Transparency initiatives including Post Marketing Commitments, Transparency in Grants and more recently Transparency in HCP payments.Global implementation FDA Regulation Part 54: Financial Disclosure for Clinical Investigators.

Directed 50 internal/external consultants & product specialists for the implementation of LBMS services & products, 50% of LBMS global consulting revenues. Managed International Services via a network of a credited Service ProvidersSuccessfully rebuilt eastern region the services group Accountable for LBMS key consulting accountst including, Merck, Astra Zeneca, Wyeth, Pharmacia, Chemical Bank, Viacom, Prudential Insurance. In addition to role of Director of Consultancy, directed LBMS strategy and execution of process & project management at GE Capital