Summary of Expertise A compliance program specialist whose area of expertise is regulatory compliance in the marketing phase of the pharmaceutical life cycle. Conducting assessments designed to measure company performance in meeting international regulatory requirements which define the pharmaceutical marketing environment. 35 years of experience in sales, sales management, the management of company sponsored medical education and scientific publication support programs, and the development and implementation of compliance assessment and auditing programs.Founder of Heartland Compliance Services LLC, a Kansas corporation providing expert consulting, training and auditing services the pharmaceutical industry for marketing and marketing related activities, with expertise in the evaluation of business processes related to pharmaceutical labeling, advertising, promotion, and educational support for compliance with regulatory requirements, company policies, and industry association standards.
Professional Experience
May 2008 - Present Heartland Compliance Services LLC Founder
August 2000- April 2008 Wyeth Pharmaceuticals Collegeville, PA
Assistant Vice President Global Compliance Auditing - Pharmacovigilance, Promotion and Labeling Responsible for ensuring that worldwide Wyeth product labels, package inserts, country specific data sheets, and advertising and promotional materials reflect complete and accurate medical content, consistent with company policy, national and regional laws, and regulations, and accepted professional standards. Responsible for ensuring that Wyeth adverse event reporting processes are in compliance with corporate policies and global regulatory requirements. Responsibilities include working with affiliate and corporate management, evaluating and recommending enhancements to current processes to assure that policy and regulatory requirements are implemented in a timely and consistent manner.
January - August 2000 Aventis Pharmaceuticals Bridgewater, NJ
Director International Drug Regulatory Affairs Coordinator Responsible for coordinating regulatory activities in the International Region (Central and Eastern Europe, Middle East, Africa, Asia/Pacific). Responsible for defining the regulatory strategy for new product/line extension submissions and approvals in the region; ensuring that global strategies incorporate regional requirements; ensuring appropriate global support and resources for the region; facilitating knowledge transfer to/from the region and countries within the region with Global Drug Regulatory Affairs (DRA); provide support to business development for regional licensing strategies; communicate the strategic vision of DRA to region/countries; ensure synergy of activities across the region and ensure quality standards and processes are maintained in the region. The focus of these activities was the support of marketed products.
1990 - 1999 Aventis Pharmaceuticals* Bridgewater, NJ, USA
Senior Director Corporate Regulatory Compliance Responsible for ensuring compliance with government regulations related to areas of commercial activity of regulatory concern (advertising, promotion, and labeling, educational support) in the countries in which HMR markets products. Responsibilities include developing positive relationships with senior country and area management in North America, South America, Europe, and Asia/Pacific, providing guidance to country personnel in interpreting regulatory requirements and developing standard operating procedures conducting regulator audits of these activities and providing regulatory compliance assessments to HMR senior corporate management. Interactions involved approximately 60 countries
* Includes Marion Merrell Dow prior to the merger resulting in the Aventis Corporation
1983-1989 Marion Laboratories Kansas City, MO, USA
Manager, Scientific Communications Responsible for the management of a 15 person staff of medical writers, graphic artists and print production specialists in the development of internal and external scientific publications and graphics. The focus of internal publications were to communicate new scientific information on Marion products and therapeutic areas of interest to the corporation to the internal sales, marketing and R&D personnel. The focus of external publications were to increase market penetration of Marion products and build the scientific support image of the corporation. Responsibilities for internal scientific publications included the design and production of the Research and Development Division’s monthly scientific newsletter, R&D’s graphic services and medical writing services. Responsibilities for marketing funded external publications included interactions with Marion marketing personnel, medical influence leaders, university medical education departments and medical publishers in the development of peer-review journal supplements, sole sponsor publications, journal articles and scientific slide kits.
1981-1983 Marion Laboratories Kansas City, MO, USA
Manager, Professional Education Responsible for developing symposia and visiting professor programs to build awareness of Marion products, developing scientific publications to increase product awareness and market penetration, and developing positive advocate relationships with key medical leaders in the fields of infectious disease and microbiology.
1979-1981 Marion Laboratories Minneapolis, MN, USA
Area Sales Manager Marion Scientific Division Minneapolis, Minnesota Responsible for management of distributor sales in the north central US/Canada (Minnesota, Wisconsin, Iowa, North Dakota, South Dakota/Manitoba, Saskatchewan). Responsibilities included establishment and maintenance of product distributorships, training and motivation of distributors sales forces, conducting customer sales and training seminars, direct sales presentations to physicians, nurses, microbiologists and buyers in the key purchasing groups. Product line: Microbiology diagnostic products.
Awards: Marion Scientific “Ring Award” (1980, 1981), Marion Scientific President’s award (1980), American Scientific Products Manufacturer’s Representative of the Year (1980), Marion Scientific Creative Award (1981).
1971-1979 Scientific Products Division, American Hospital Supply Corp
Sales Representative Wichita, Kansas Sales representative for laboratory products involving approximately 60,000 line items of diagnostic tests, laboratory supplies and laboratory instrumentation. Called on physicians, medical technologists and purchasing agents in clinical, hospital, industrial, educational and federal laboratories in. Wichita and southeastern Kansas. Sales Representative Colorado Springs, Colorado Product line and customer base same as above. Territory: Colorado Springs and southern Colorado.
Awards: Scientific Products President’s Award for highest gross profit increase; Ames Distributor Representative of the Year; Instrumentation Laboratories Distributor Representative of the Year
Clinical Sales Manager, Chicago Region Scientific Products Division Chicago, Illinois Responsible for the management of 22 biomedical sales representative and 19 field service representatives in the Chicago sales region (Illinois, Indiana, Iowa, and American Wisconsin). 1965-1970 St. John’s Hospital Springfield, Missouri, USA
Medical Technician
Performed diagnostic laboratory testing in hematology, chemistry, and blood bank departments. Took night call for five years while attending undergraduate and graduate schools.
1962-1965 United States Marine Corps
Education
1965-1969 Bachelor of Science, Biology Southwest Missouri State University Springfield, Missouri, USA
1969-1970 Master of Arts, Biology Southwest Missouri State University Springfield, Missouri, USA
1970-1971 Post Graduate studies: Animal Behavior University of Missouri Columbia, Missouri, USA
