Medical Editor

Medical Editor

Contract Opportunity, 2 years

Hybrid- Northern suburbs- 3 days onsite/2 days WFH

Our client, a global pharmaceutical company is seeking a detail-oriented Editor to support the review of promotional, non-promotional and internal use materials. This role ensures content is accurate, compliant, and aligned with company standards before distribution to healthcare professionals and consumers. This individual will focus on and support FDA Ad Promo Submissions as well as support QC and regulatory reviews of the materials.

Responsibilities:

• Coordinate promotional and non-promotional materials review and approval processes
• Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly
• Perform Quality Check review on the materials prior to routing
• Facilitate meeting discussions and document outcome in live meetings while conducting meeting efficiently to cover the full agenda
• Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates.
• Complete regulatory review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary
• Develop and update training resources on materials review process and Veeva functionality. Train sponsors, agencies, and reviewers as needed
• Manage user profiles, training needs and access to the VeevaPromomats to sponsors, agencies, and reviewers
• Serve as a point of contact to Veeva vendor for ongoing maintenance and optimization of Veeva workflows. Assist with Veeva Promomats IT validation
• Generate Veeva metric reports to help with process improvement, resource management and compliance monitoring
• Archive OPDP correspondence per guidance from Reg Ad promo lead
• Contribute to development and update of departmental work instructions
• Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission
• Support other departmental initiatives as needed (e.g. process improvements)
  
  

Top Skills:

• Document-Quality Check
• Good organizational and time management skills
• Strong communication, both oral and written
• Ability to innovate, analyze, understand customers' needs with minimal supervision
• Proficient with computer systems and/or pharmaceutical software
• Past experience in prescription drug advertising/promotional labeling and/or promotional labeling submissions desired
• Knowledge of procedures and requirements regarding prescription drug advertising and promotional materials desired

Qualifications:

• Bachelor's degree in technical or science related discipline or related work experience
• 3+ years in Regulatory, Quality or related area
• Experience in a complex and matrix environment
• Experience in pharmaceutical industry preferred

While on assignment Digital People is proud to offer major medical, dental, vision, and 401K benefits!

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