Submission Specialist, Pharma

USA | Full-time | Fully remote

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You’re a go-to expert on the medical, legal, and regulatory submission process and tools who prides themself on ensuring flawless documentation. You’re energized by the challenge to make a complex submission simple to navigate and are committed to keeping yourself and the team informed and optimally working together. And, above all else, if you want to join a global team that creates smart, creative and impactful digital experiences that solve complex challenges, we would like to meet you!

Modus is a digital agency based in New York City with offices throughout the United States, Buenos Aires and Manila. We’re an interdisciplinary group of motivated, dedicated professionals who don’t take things at face value. We uncover insights, imagine new possibilities, and create digital experiences that transform businesses and delight customers.

Our next Submission Specialist will be an integral part of our growing

Product team, working with one of our industry-leading pharmaceutical clients.

Read on for details.

Responsibilities: 

  • Coordinate, prepare and maintain accurate documentation for submission to medical, legal, and regulatory review panels 
  • Prioritize work, manage submission calendar, and resolve submission issues in collaboration with Product Managers, Product Owners, Content, UX, and Brand teams
  • Ensure correct representation of all mandatory, Prescribing Information (PI), and Important Safety Information (ISI)
  • Ensure all project forms, briefs, functional annotations, layout indicators, tagging, and linking of references are included and accurate
  • Review and confirm MAP codes, end matter, files formats, and naming conventions adhere to guidelines
  • Apply an understanding of OPDP submission requirements and complete QC checks
  • Participate in content planning and review sessions
  • Stay abreast of regulatory updates, training, and documentation requirements and monitor all stages of project for accuracy 
  • Provide submission guidance to team and look for ways to continuously improve process 

Qualifications:

  • 4+ years of relevant agency and/or pharmaceutical industry experience 
  • Copy, editorial, or project management background is a plus
  • Deep knowledge of MLR review and submission processes
  • Strong self-management skills with ability to stay organized while juggling multiple projects and deadlines
  • Proactive communicator with excellent interpersonal skills who can work collaboratively within a cross-functional team of Product Managers, Copywriters, UX Designers, and Brand Owners
  • Excellent oral and written communication skills
  • Exceptional attention to detail
  • Proficiency with Microsoft Office, Adobe Acrobat, and MLR submission software
  • BA/BS (or equivalent) preferred

In addition to a competitive salary, Modus offers a great work environment, premium health care plans, 401k matching, flexible work schedules, training courses and certifications, the opportunity to work with the latest technologies, and other great benefits.

If you are self-motivated and enjoy being part of a diverse team of talented people who are helping to invent the digital future, apply now!