Execute across the full range of activities in the strategy development and operationalization process – problem definition, framework development, hypothesis generation, data gathering, robust analysis, synthesis of findings, development and presentation of clear recommendations, business case development, and assisting with the implementation and management of key strategic initiatives.
●Supported Medical Affairs senior leadership in refining and executing their Medical strategy, optimizing customer intelligence, HCP engagement approach, digital enablement, content fitness, and governance.

Served as primary compliance business advisor to the U.S. Medical Affairs organization. Worked closely with Medical Directors/Field Medical to enable them to conduct their business activities more efficiently while mitigating risk and maintaining a high standard of compliance.
●Provided compliance and business process expertise to global cross-functional team streamlining process and implementing new enterprise-wide system for documenting interactions with Healthcare Professionals/Organizations (HCPs/HCOs)
●Developed novel training provided to all U.S. medical science liaisons (MSLs) and other field medical personnel on compliant interactions with their commercial colleagues.

Acted as chief of staff to U.S./Headquarters Compliance Officer. Optimized and led execution of key management processes and operations. Led organization's transformation projects. Facilitated departmental meetings, workshops, and training sessions. Prepared meeting quarterly/ad-hoc reports for key program oversight governance bodies.
●Developed organizational proposal to streamline/standardize compliance organization and presented to executive management. Successful implementation resulted in operational efficiencies and cost savings exceeding $5M. MICHELLE I.
●Facilitated post-merger organizational integration and development of new organization's charter, strategy, goals, objectives, and policies/procedures.

Partnered with senior management to lead a variety of enterprise-wide and cross-functional initiatives in support of CEO's transformation strategy. Managed all facets of projects including business needs analysis, scoping and planning, current state assessment and gap analysis, solution design and recommendations, training and implementation, and post-project reviews.
●Led global cross-functional expert team that defined enterprise-wide clinical trial process model and developed key performance indicators (KPIs) for overall process as part of global process standardization initiative. Received Visionary Award (highest level of achievement in corporate recognition program) from CEO.
●Designed and successfully implemented formal assessment tool, balanced scorecard/results dashboard, and executive report to evaluate overall quality and efficiency of corporate compliance program and internal audit function. Prepared and presented C-level suite and Board of Directors quarterly reports.
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Led and supported compliance risk mitigation activities for business transformation projects to pharmaceutical and medical device clients. Developed and managed project plans, and acted as primary client liaison during multiple engagements. Served in multiple enterprise-wide program management offices (PMOs).
●Managed/performed compliance activities for global computer system implementations, including enterprise resource planning (ERP), document management, learning management, and clinical data management systems.
●Conducted compliance risk assessments and determined risk mitigation activities. Developed compliance strategy documents, validation plans/protocols, and SOPs/work instructions. Conducted vendor audits and prepared audit reports. Enabled knowledge transfer and trained staff on relevant regulations and GxPs.