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    Submissions Regulatory Coordinator - New York, United States - VML

    VML
    VML New York, United States

    3 weeks ago

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    Description
    Who We Are:

    At VML, we are a beacon of innovation and growth in an ever-evolving world. Our heritage is built upon a century of combined expertise, where creativity meets technology, and diverse perspectives ignite inspiration. With the merger of VMLY&R and Wunderman Thompson, we have forged a new path as a growth partner that is part creative agency, part consultancy, and part technology powerhouse.

    Our global family now encompasses over 30,000 employees across 150+ offices in 64 markets, each contributing to a culture that values connection, belonging, and the power of differences. Our expertise spans the entire customer journey, offering deep insights in communications, commerce, consultancy, CRM, CX, data, production, and technology. We deliver end-to-end solutions that result in revolutionary work.

    Who we are looking for:

    The Regulatory Submission coordinator is responsible for collaborating with the internal client team in the preparation and delivery of materials for submission to our Pharmaceutical clients for Medical/Legal/Regulatory (MLR) review. This includes creating components of a submission package (both electronically and/or in hard copy as needed), managing references, including collecting and validating according to VML Health or client specifications, facilitating communication among team members about the status of projects and producing all final materials being delivered to the client, including making PDFs, researching and accessing materials for binders and ordering all materials associated with submission

    What you'll be doing:
    • Submit completed materials to the client, both electronically and/or in hard copy, as determined by the clients' specifications, including the "tagging and linking" process which electronically identifies and joins claims to their specific citations eg, journals, data on file documents, posters
    • Responsible for referencing process for materials submitting into the systems
    • Works closely with the Copywriter and/or Medical Editor to ensure the accuracy of the of the reference information within the client system Represent Wunderman and establish productive relationships with appropriate client MLR review board coordinators to assure that the Agency is following MLR submission best practices
    • Coordinate, assemble and/or prepare for submission various pre and post approval materials to the FDA for consumer marketing materials review
    • Responsible for working with manager to ensure tracking of submissions on a daily and weekly basis by Maintaining a comprehensive and accurate record of all current and upcoming submissions including the stage of review, job codes, references, and deadlines
    • Works with Manager to enforce strict preset procedures and regulations set forth by client MLR review teams and FDA guidelines
    • May also be asked to attend and contribute to internal team status meetings
    • Submits timesheet accurately and in a timely manner
    • Adheres to the estimated time allocated for submissions task
    • May also be asked to work with Project Management team to assist in ensuring estimates are entered into the financial system (JDE)
    What You'll Need:
    • Experience in Pharmaceutical Industry or Healthcare is preferred, but not required
    • Comfortable learning and mastering multiple client submission platforms, or familiarity with similar technologies and digital platforms
    • Must have Strong communication skills, be very detailed oriented and have strong problem- solving skills
    • Ability to successfully organize, prioritize and manage complex projects in a deadline-driven environment
    • Need to be a positive collaborator and team player
    • Excellent spelling, grammar and proofreading skills
    • Proficiency in Windows and Mac programs, web and mobile platforms, Microsoft Office Suite Adobe Acrobat
    • Ability to follow strict procedures and meet deadlines
    • Interest in Regulatory Affairs, Journalism or Pharmaceuticals field is useful, not required
    VML Health is an equal opportunity employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability, or other protected group status. We believe in creating a dynamic work environment that values diversity and inclusion and strives to recruit a diverse slate of candidates to help us achieve that goal.

    The base salary range for this position at the time of this posting is indicated below. Individual compensation varies based on job-related factors, including location, business needs, level of responsibility, experience, and qualifications. We offer a competitive benefits package, click WPP Benefits for more details.

    $40,000-$85,000 USD

    At VML, we are committed to fostering an all-inclusive work environment that is both rewarding and career-forward. Our Inclusion, Equity & Belonging initiatives, alongside the VML Foundation, reflect our dedication to giving back and making a positive impact in our communities and beyond. Our people are the heartbeat of our organization-creators, doers, innovators, makers, and thinkers-who drive not just marketing, but meaningful experiences that resonate in every action and interaction.

    VML is a WPP Agency. For more information, please visit our website, and follow VML on our social channels via Instagram, LinkedIn, and X.

    When you click "Submit Application", this will send any information you add below to VML. Before you do this, we think it's a good idea to read through our Recruitment Privacy Policy. California residents should read our California Recruitment Privacy Notice. This explains what we do with your personal data when you apply for a role with us, and, how you can update the information you have provided us with or how to remove it.
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