• Medical Legal Regulatory Submissions Specialist

    Job ID
    2020-19714
    Location
    US-NY-New York
    Category
    Copy
    Company
    TBWA\WorldHealth
  • Overview

    tbwa-worldhealth logo

     

    Title: MLR Submission Specialist

     

    YOU ARE THE GATEKEEPER:


    You’re the guru of all things submissions, and executing them flawlessly truly brings you pride. Your team and clients depend on your ambition to keep a perfect track record. Your eagle eyes spot mistakes before they’re ever allowed to happen, in no small part thanks to your strict adherence to guidelines and your tech savvy. Your checklist is your Rosetta Stone, and with it you make sense of the thorniest submissions with confidence and ease. Your MLR CM, Copy, and Account partners, and even your clients, are confident you’ll make them look good when their tactics are scrutinized. You’re skilled at navigating submissions platforms that are often notoriously tricky and can guide others safely past the pitfalls. But you don’t stop there—you’re always on the lookout for ways to improve the process and enjoy giving your coveted submission checklist regular tune-ups. 

     

    YOU WILL BE EXPECTED TO:

    Keep it under control (30%)

    • Become familiar with client procedures and guidelines on how to successfully submit a job for MLR review
    • With guidance frmo MLR content managers, create, uphold, and maintain submission checklists per brand
    • In collaboration with Copy, organize references to streamline the project submissions

    You will excel by: 

    • Being bold in identifying and brave in communicating ways to make submissions more efficient 
    • Collaborating with teammates from other departments 
    • Owning all reference management for your assigned brands

     

    Know your stuff (20%)

    •  Be an expert on regulations for FDA and OPDP submissions
    • Stay current with new electronic submission and regulatory documentation practices and standards

    You will excel by: 

    • Actively seeking out training opportunities and industry developments
    •  

    Make it seamless (50%)

    • Manage multiple submissions and deadlines
    • Prepare for submissions by: Performing QC of submission components prepared by team prior to submission, tagging and linking references, fact-checking claims as needed, annotating any comments relevant to MLR reviewers prior to submission
    • Press “go” on submissions

    You will excel by: 

    • Understanding the needs and challenges of clients
    • Working independently, with minimal supervision

     

    POSITION REQUIREMENTS: 

    • Bachelor’s degree 
    • 2+ years of relevant work experience, preferably in science, medicine, or at a pharmaceutical advertising agency 
    •  Ability to thrive and grow in a fast-paced environment 
    • Extremely detail-oriented and organized approach 
    • Proficiency in Microsoft Office (Word, Outlook, Excel, PowerPoint) and Adobe Acrobat 
    • Familiarity with Veeva PromoMats and PubMed


    A FOUNDATIONAL SKILL SET DEFINED BY: 

    • Ability to work collaboratively with multiple departments and levels within the agency 
    • Strong team-oriented approach and excellent interpersonal skills 
    • Ability to prioritize deadlines and work under pressure 
    • A passion for sciences and regulations 
    • Technological savvy

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed