Marketing Operations Specialist - Remote - Part Time to Full Time

6 hours ago

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OneSource Regulatory (A ProPharma Group Company)

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Regulatory Affairs • Compliance • Medical • Pharmaceutical Industry • Biotechnology

11 - 50

Description

• Join the OSR Team to transform Marketing/Commercial Operations and the way you work. • OneSource Regulatory (OSR), is seeking qualified Marketing Operations Managers based in the US. • Coordinate and oversee the promotion review process as well as other promotion related processes for assigned brands or therapeutic categories. • Responsible for forecasting promotion review team needs, through collaboration with sales communications, training, brand managers, and other marketing support functions. • Lead all prioritization discussions for the assigned promotion review team and communicate agreed upon agendas to reviewers and job owners who will be presenting during the meeting. • Provide counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review. • Provide oversight of materials being added to the promotion review team agenda to ensure that minimum quality and promotion review guidance has been followed. • Facilitate promotion review team meetings to ensure meetings are efficient and conducted according to guidance. • Communicate information provided during promotion review meetings to the broader team when appropriate. • Clarify, review, reconcile, and document the comments on review materials during live PRC meetings & ensure final approval from PRC reviewers. • Oversee the copy proofing process and production process of final approved materials with agency/external partners. • Interact with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use (Form FDA 2253). • Partner with job owners and other stakeholders in the execution of job reapprovals and tactics related to label changes for assigned brands.

Requirements

• Bachelor degree is required (Focus in Business, Medical, Science, Marketing, or Communications is preferred) • 10+ years of related experience in the pharmaceutical/ biotech industry is required (For Sr level team leader roles) - May consider related experience from healthcare advertising agency • 7+ years related experience in the pharmaceutical/ biotech industry is required (for individual contributor roles on the team) - May consider related experience from healthcare advertising agency • Functional experience in regulatory, medical, pharmaceutical marketing operations, sales or communications preferred • Product launch or advertising agency account management experience is a plus. • Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion • Understanding of pharmaceutical review and approval process is preferred • Deep understanding of the advertising/creative development process • Strong project and process management experience (in pharma industry preferred) • Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. • Proficiency in Veeva Vault Promo Mats or other electronic review platforms.