Associate Director of Compliance and Literature Review

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2006 sales were in excess of $2.2 billion. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis. For more information, please see www.merial.com. 

 

Job Description:

Purpose: As part of the Literature Quality Assurance Process (LQA) review, edit and provide critical commentary on all Merial US advertising and promotional literature in a timely manner, insuring that the materials are scientifically correct and in compliance with FDA, EPA, USDA and legal requirements; advise marketing, sales training, regulatory and legal personnel on compliance matters related to such materials and to competitors’ materials. Have in depth knowledge of Merial and competitors’ products and supply the appropriate references to legal and Regulatory Affairs as necessary. Interact with Regulatory Affairs and legal concerning matters, and work to help provide resolutions regarding materials that come before the LQA Clearance Committee. Working with the Director of Compliance and Literature Review, educate and monitor the US marketing and sales teams to ensure that Merial meets all regulatory and compliance requirements. In addition, the individual is responsible for managing the e-room database that provides the technical support for all of marketing materials and the reference center of US Veterinary Services, Technical Solutions and the marketing team.

Major responsibilities: 1. Conduct LQA reviews of US promotional materials--including technical materials-- editing and providing critical commentary as necessary. 2. Advise legal and regulatory on the scientific basis of letters from competitors and the validity of Merial promotional pieces. 3. Support marketing by advising and providing scientific input for marketing programs and initiatives. 4. Interact with and assist in the development and review of training materials for new sales representatives. 5. Assist the Director of Compliance in his day-to-day activities. 6. Supervise the LQA Specialist. 7. Support marketing, Merial Field and Technical Solution veterinarians by maintaining and expand the electronic article database and other e-room functions. 8. Participate in LQA Clearance Committee meetings.

 

Qualifications:

Knowledge and skills: 1. In-depth knowledge of veterinary medicine, animal diseases and animal health industry products. 2. Excellent writing and editing skills. 3. Ability to learn and accurately apply to the review and editing process relevant federal regulations, including sections 503(f) 1 and 502(f) 1 of the Food and Drug Cosmetic Act, USDA memorandum 800.98 on advertising and promotion and 21 CFR sections 200-299, 500-599 and part 320, plus FDA Guidance’s on Advertising and Promotion and 40 CFR sections 168.22 and 156.10. 4. Working knowledge of the veterinary pharmaceutical and biological industry and their practices (5 years experience in industry). 5. Good computer skills and the ability to organize and prioritize. 6. Excellent interpersonal skills and the ability to problem solve. 7. Ability to work on their own without direct supervision. 8. Ability to interact, direct and lead groups that may not be direct reports. 9. A DVM or VMD degree is required.

EEO/AA/M/F/D/V