Job Description

REMOTE ROLE  Description: • Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product LABELING AND ADVERTISING MATERIALS. • Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB SUBMISSION. • Provide a leadership role on the REVIEW COMMITTEE (RC) by providing regulatory guidance on PROMOTIONAL LABELING AND ADVERTISING MATERIALS • Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines. • Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives. • Work collaboratively with medical and scientific personnel on the development and review of materials related to ADVERTISING AND PROMOTION. • Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations. • Serve as FDA liaison for matters related to the advertising and promotion of assigned products Years of Experience: 6 plus years

REMARKS:

Need someone with at least 7 years in Regulatory ad/promo experience. They will need someone who requires minimal oversight. In addition this person will be certifying material compliance to the FDA on behalf of Sanofi, and as such it is imperative they have adequate experience and background to perform that role, especially given the CIA. This is a remote position, think big, this team is looking for quality and experience, so find the best candidate. REMOTE.

Company Description

MaxisIT® is the Clinical Software Organization & only Integrated Software Platform for Biopharmaceutical industry.