Leading a team of global regulatory professionals, setting regulatory strategy and direction across a multi-billion dollar portfolio of assets, and ensuring appropriate resourcing and training to deliver the portfolio. Accountable for talent management, and development of employees. Championing regulatory innovation, while ensuring delivery of projects with quality and speed. Extensive experience in late phase clinical development, new drug submissions and approvals, labeling, claims development, line extensions, and agency communication. Accountable for regulatory success of the portfolio, and external and executive communications.

Leader of an organization that provides actionable insights based on competitive intelligence, surveillance, and analyses that informs R&D strategy across the Lilly portfolio of medicines and for business development opportunities.

Regional regulatory leader for molecules in development; Accountable for the regulatory success of high priority and complex molecules in development; Provide strategic regulatory oversight and maintain regulatory accountability on molecules in development; Provide high quality, timely and decisive regulatory advice enabling business partners to make well-informed decisions on development and life-cycle planning; Communicate regulatory impact on product development plans; Integrate information from the external environment, competitor programs, FDA meetings, product specific regulatory advice, regulatory trends, and other information to develop robust regulatory strategies; Generate, review, and approve regulatory documents for medium to high complexity submissions, ensuring appropriate data/information and clearly articulated positions; Build, maintain, and leverage relationships with FDA, team members, and partner companies; Assess product risks and effectively communicate regulatory probability of success to set expectations with internal leadership; Anticipate and resolve key technical, operational, and strategic issues that have the ability to impact regulatory strategy or development programs; and Determine and communicate submission and approval requirements.

Provide strategic, tactical, and operational direction and timely, decisive regulatory advice for working within US regulations; Evaluate regulatory impact on proposed product development plans by understanding, investigating, and evaluating regulatory authority requirements and expectations, regulatory history, disease/therapeutic context, and competitor programs; Facilitate FDA interactions and responses to regulatory authority requests; Lead development teams in the creation of submission documents, ensuring compiled submissions meet applicable regulatory requirements.

Primary liaison and consultant representing medical writing across the autoimmune/biologic therapeutic area; Developed and coordinated multiple and diverse regulatory document plans and timelines across global geographies and all phases of drug development; Influenced clinical planning/trial development, FDA and European submission strategy planning, and regulatory responses/briefing document strategies; Forecasted medical writing needs and developed sourcing strategy in collaboration with management. Was accountable for execution of strategy and anticipated and resolved sourcing conflicts.

Primary document custodian (first draft author, project manager) for clinical regulatory documents including protocols, clinical study reports, investigational brochures, clinical summaries for investigational new drug/IMPD applications, regulatory responses, briefing documents, and other clinical summary and global submission documents.

Developed lesson plans, course materials, and arranged for guest lecturers/panels to teach an undergraduate epidemiology course (topics included: study designs, descriptive statistics, measures of association/effect, causality, morbidity and mortality, chronic and infectious disease epidemiology, international health, and ethics in human research).

Trained breast cancer clinic physicians, fellows, nurses and study staff on epidemiologic theory and practical methods, human subject research, informed consent and data collection procedures; Streamlined breast cancer patient data collection forms, implemented procedures and policies to correct and prevent systematic data errors and devised a new research work plan to resolve duplication of efforts; Created an integrated research database system with supporting documents, hired and trained database personnel, managed data entry for approx. 10,000 participants and developed a validation plan for database assessment.

Developed budgets for industry sponsored clinical research, negotiated, obtained approval, and executed contracts in cooperation with health care practitioners, hospital and industry administration and attorneys for all hospital units; Created and prepared regulatory documents and research summaries for internal review board submissions and tracked more than 50 studies, phases I to IV for drug and device trials, through pre- and/or post-award procedures.