Pharmaceutical Industry professional with 28+ years of experience. Strong background in a variety of therapeutic categories and broad experiences developed through sales, managerial, analytical, marketing, operations, and compliance positions. Solution oriented with an eye towards driving business results.
Global Compliance Officer February 2015 to CurrentNovartis Cell&Gene Therapies － East Hanover, NJ
Responsibe for ensuring processes which encourage associates to behave ethically/lawfully and prevent/detect inappropriate conduct, champion ethical conduct throughout the Cell & Gene Therapies Unit (C>U).
Responsible for development of the global ethics & compliance training program for C>U associates.
Advise BU senior management on interpretation of company codes policies.
Chartered and Chair the C>U compliance committee.
Trained senior management on Conflicts of Interest, Anti-Bribery, and Medical-Commercial Interactions.
Represent the C>U on various company committees such as: Division Compliance Committee, Pharma Compliance Leadership Team, and NPC Compliance Committee.
Ensure internal investigations regarding C>U activities are conducted thoroughly and fairly in close coordination with the Business Practices Office.
Developed , Refined, and Rolled out Risk Assessment program for the C>U.
Ad-interim Global Compliance Officer March 2014 to February 2015Novartis Global Oncology － East Hanover, NJ
Oversaw and monitored the effectiveness of the Oncology integrity and compliance program.
Reviewed all events, grants, and other funding agreements.
Developed and maintained collaborative relationships with global/regional/local business leaders to ensure understanding, and support for compliance activities.
Advise the Oncology General Counsel and Leadership Team regularly regarding Compliance obligations, risks and risk minimization strategies, actual or potential compliance-related issues, investigation resolution of such issues, and corrective actions.
Worked with Commercial Operations throughout the GSK merger to secure a policy exception for promotional materials which allowed continuity of the business upon deal closing.
Oversaw Oncology policies and procedures globally for NP4 and related areas.
Monitored advisory boards and global stand alone meetings.
Operationally and functionally lead a global team.
Participated as a key member of the Pharma Compliance Leadership Team, and Division Compliance Committee by actively contributing to the design, prioritization and implementation of Pharma Division initiatives to further build an effective compliance program.
Director January 2010 to February 2015Novartis Oncology － East Hanover, NJ
Responsible for driving major elements of Novartis Oncology's US Compliance program.
Coordinated with multiple internal teams to ensure compliance with laws, regulations and guidance affecting the pharmaceutical industry including FDCA, OIG Guidelines, PhRMA Code, ACCME Guidelines, Anti-kickback Statute, False Claims Act, PDMA, DRA, state laws and customer/institutional policies.
Coordinate with Oncology Global Compliance Officer to ensure consistency between US and Global practices.
Represented Oncology and worked toward implementation of the Novartis Corporate Integrity Agreement.
Draft, review and implement policies, policy certifications, refreshers and guidance documents.
Develop and administer live and web-based training for Field Sales, Marketing, Managed Markets.
Coordinate compliance audits, draft and implement audit remediation plans.
Conduct internal investigations and work with management to evaluate and determine corrective action.
Provide ongoing counsel and advice on business practices.
Director July 2008 to December 2009Novartis Oncology － East Hanover, NJ
Responsible for overseeing implementation of compliance policy within the Business Franchises and associated departments.
Point person for AHM conversion for the OBU.
Served as Function Operations Designate, FOD, and managed compliance communications.
Member of the Oncology EOC Committee.
Served on the BFLT, SLT and pre-SLT teams.
Worked collaboratively with Sales Ops to plan and execute national sales "H" meetings, Manager Meetings, ad hoc meetings and launch meetings.
Serve as BU interface for ad hoc General Medicines initiatives (examples of initiatives: State Law Compliance, Privacy, Fair Market Value, Advertising Excellence, Concerto Data Integration, Speaker Contracting, and Transparency Team.
Director July 2007 to July 2008Novartis Oncology － Florham Park, NJ
Managed all Sales Operations functions as it relates to Field Force readiness.
Involved in duties such as managing Field Force Expansion processes, coordinating and facilitating processes to improve field force implementation and execution.
Managed business planning cycles which includes development of processes and controls for budgets, plans and headcount.
Actively worked with team to develop integrated compensation plans for the sales forces.
Managed Communications for the sales forces.
Director/Senior Product Manager January 2004 to July 2007sanofi-aventis － Bridgewater, NJ
Developed programs and tactics that drove the strategic objectives for Uroxatral.
Worked to motivate the sales force in the promotion of Uroxatral.
Managed multi-million dollar budget and agency relationships to complete work that support the objectives of Uroxatral.
Chaired the Urology review committee for Uroxatral, Eligard, and Taxotere.
Led efforts on co-promotion opportunities with potential partner companies in the urology space.
Associate Director July 2002 to December 2003sanofi-synthelabo － New York, NY
Worked closely with Sales Operations on behalf of the Internal Medicine Business Unit and the National Sales Director's to analyze and develop important business questions.
Shaped the optimization of the AriXtra sales force for the Organon/sanofi~synthelabo joint venture.
Business Manager July 2001 to July 2002Roche Laboratories, Inc － Nutley, NJ
Responsible for improving the focus of the National Account Sales Force.
Re-deployed National Accounts team as well as determination of both IDN and Specialty Care accounts.
Created AMTRACK system to focus account teams on targeted customers.
Manager May 2000 to June 2001Roche Laboratories, Inc Geographic Information Systems － Nutley, NJ
Managed the design, development, and implementation of a sub-national information platform which unified sales data and analytics.
Project Manager responsible for analyzing national hospital segmentation for $650 million infectious disease product.
Project Manager responsible to the complete re-alignment and re-targeting of the 223 member Virology and Hepatology Sales Forces.
Business Manager January 1999 to May 2000Roche Laboratories, Inc － Overland Park Kansas City, KS
Worked with Business Unit Management team to orchestrate the Xenical Launch Plan.
Created Tamiflu Business Unit Launch and Pre-Launch Plans.
This plan helped to lead our business unit to the highest percentage of representatives to goal achievement.
Division Sales Manager December 1996 to December 1998Roche Laboratories, Inc － Overland Park, KS
Managed a team of 13 hospital sales professionals.
Senior Territory Business Manager September 1988 to December 1996Bristol-Myers Squibb － Overland Park, KS
Responsible for the promotion and sales of Bristol-Myers Squibb products to physicians, nurses, and pharmacists.
M.B.A : Quantitative Analysis, December 1994The University of Missouri - KC － Kansas City, MOQuantitative Analysis
B.A : Human Biology, May 1988The University of Kansas － Lawrence, KSHuman Biology
Healthcare Compliance Certification : Oct 2010
Editorial Advisory Board PM 360 Magazine Sept 2012- Present eXl Pharma Practical Considerations for Advisory Boards" : May 10, 2012Seton Hall School of Law － Newark, NJ