Created as a joint-venture between Nestle and L'Oreal, Galderma is a leading player in the wordwide dermatology market. Galdlerma develops and markets innovative therapeutic, corrective and aesthetic solutions for the prevention, diagnosis and treatment of dermatological conditions.
We presently have an excellent opportunity in our Regulatory Affairs Promotions and Labeling Review Group. This position is based in our Fort Worth, TX headquarters which is located at Alliance, 15 miles north of Downtown Fort Worth. Please read the qualifications, duties and responsibilities carefully. If you qualify, please consider applying for the position. A candidate should have three years experience with a pharmaceutical company participating in reviewing and approving promotional and advertising materials such as websites, pamphlets and journal or magazine advertisements.
In addition to a competitive salary we offer an excellent benefits package that includes medical/life/dental/vision/prescription insurance, tuition reimbursement, flexible spending accounts, vacation and sick time as well as a generous 401(k).
ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned)
Review and evaluate advertising and promotional materials utilized by Galderma to promote its products to consumers or to the medical community for compliance with applicable FDA, FTC and state regulations regarding such activities. This work requires:
- Knowledge and understanding of FDA and FTC regulations regarding pharmaceutical and medical device company promotional activities
- Knowledge and understanding of clinical statistics, evaluation of clinical and non-clinical data and how these relate to proper support for medical, commercial or statistical claims in promotion
- Knowledge and understanding of PhRMA, AdvaMed and OIG codes with respect to interactions between pharmaceutical and medical device companies and healthcare professionals regarding promotion of pharmaceutical and/or medical products
- Working knowledge of the appropriate methods and means of advertising and promotion of pharmaceutical and medical device products
- Working knowledge of the laws and regulations applicable to labeling of prescription and OTC drugs, and cosmetics
Maintain up-to-date information regarding initiatives by FDA, FTC and other applicable regulatory authorities relating to the promotion of pharmaceutical, device and cosmetic products
Participate in the review of all regulated printed items to ensure regulatory compliance.
This includes Rx and OTC packaging and inserts, promotional pieces and websites.
Coordinate with team members to resolve any regulatory problems.
EDUCATION and/or EXPERIENCE
Bachelor's degree in Life Sciences from a four-year university is required with an advanced degree preferred. Minimum of three years of experience in review and evaluation of clinical data preferred. Experience in the area of review of advertising or promotion of pharmaceutical products is required. Regulatory Affairs professiona preferred. In order to function effectively, the incumbent must have a thorough working knowledge of the pharmaceutical industry including regulatory requirements for labeling, promotion and advertising of prescription medical products. Must be proficient with MS Office including Word, Excel, Outlook, PowerPoint and Access. To apply for this position CLICK HERE
To view other Galderma jobs visit our CAREERS PAGE
Thank you for submitting your resume for this position. Due to the volume of resumes that we receive, only those candidates selected for interviews will be contacted. Galderma Laboratories offers a competitive salary with excellent benefits.
Galderma is an equal opportunity employer. M/F/D/V
No agencies please!
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