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Submissions Coordinator - A23

📁
Integrated Production
💼
Area 23
📅
200001KP Requisition #

JOB OVERVIEW

The Regulatory Operations Manager is responsible for consistent submission success. They have full knowledge of all brand submission requirements, are responsible for working with producer and account partners in assembling all submission components including the tagging, linking and uploading of submission files and support materials (including references).The Manager will also take screenshots as needed, as well as maintain the master tag ID, claims lists, and submissions calendar. They develop and maintain a relationship with client side submissions personnel, ensuring expectations are met, submissions are tracked, and potential issues are mitigated.

 

JOB DUTIES & RESPONSIBILITIES
  • Collaborate with the account and integrated production teams to prepare and submit completed digital and print creatives for medical/legal/regulatory (MLR) submissions
  • Assist in training junior staff members as needed
  • Establish and cultivate relationships with MLR counterparts to discuss submissions, MLR reviews, and any relevant updates
  • Enforce industry standards for all Medical/Legal/Regulatory submissions perFDA/OPDP regulations to agency and Pharmaceutical Client specifications
  • Tag and link within e-submission portals for various brands
  • Schedule and manage multiple brand weekly or daily submission status meetings
  • Maintain an archiving system that tracks and records all submission files and final materials
EDUCATION
DEGREE/DIPLOMAAREA OF STUDYREQUIRED/PREFERRED
Bachelors


LICENSES & CERTIFICATIONS

    EXPERIENCE
    MIN YEARSAREA OF EXPERIENCEREQUIRED/PREFERRED
    3 yearsin pharmaceutical advertising agency or in another highly regulated industryPreferred

     
     
    For U.S. Job Seekers

    It is the policy of FCB and any of its affiliates to provide equal employment opportunities to all employees and applicants for employment without regard to race, religion, color, ethnic origin, gender, gender identity, age, marital status, veteran status, sexual orientation, disability, or any other basis prohibited by applicable federal, state, or local law. EOE/AA/M/D/V/F.

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