Careers

Wanted: Regulatory Data Specialist

Let’s be honest: regulatory data isn’t for everyone. Maintaining focus, precision, and fastidiousness, all while not getting burnt out by lots of data entry and a neverending stream of regulatory feedback, that’s not everyone’s cup o’ joe.

But if that most definitely is your thing, then you might just be the one.

Being a good submission software specialist takes mental endurance, organization, and thoroughness. Life at the agency is rigorous, and to succeed here, you have to work very hard. But in your hard work, you will be joined by the most talented, intelligent, and inspiring group of people you’ve ever been around. That is not an overstatement. The culture is demanding, motivating, and rewarding all at the same time.

The stakes are high. This job is tailor-made for someone who cares about getting it right and not settling for anything less than accurate and properly submitted data.


DESCRIPTION

2e Creative (www.2ecreative.com) is a fast-growing, energetic and passionate brand communications agency focused on healthcare, pharma, medical device and life science. 2e was named “Small Agency of the Year” by Medical Marketing & Media (MM&M) for two years running (2015, 2016), and 2014 “Healthcare Agency of the Year” by Advertising Age and Modern Healthcare. We seek a qualified individual to fill the position of Regulatory Data Specialist. The Regulatory Data Specialist is responsible for organizing, maintaining and submitting promotional materials for approval via our client’s digital regulatory management platforms.

REQUIREMENTS

  • Bachelor’s degree (minimum), preferably in communications or health sciences field
  • At least 2 years of experience handling documentation and data entry for regulated industry
  • Healthcare or regulatory experience is preferred
  • Regulatory software experience is strongly preferred

QUALIFICATIONS

  • Not just a mastery of accuracy and attention to detail, but a love of accuracy; meticulousness will be a defining feature of the ideal candidate
  • Strong skills in time management, prioritizing, organizing, and problem solving, all with an eye towards efficiency
  • Strategic aptitude and flexibility; able to find work-arounds for problems
  • Familiarity with promotional regulatory management platforms (i.e., Veeva, eMAP, Zinc)
  • Ability to work autonomously and collaboratively
  • Familiarity with Food and Drug Administration (FDA) regulations regarding promotional pharmaceutical advertising
  • Proficiency with standard software: Microsoft Word, PowerPoint, Excel, Adobe Acrobat
  • A passion for science and medicine

RESPONSIBILITIES

  • Prepares agency creative source material for computer entry by gathering, sorting, and confirming references, and verifying promotional material description with qualified team members
  • Reviews data for deficiencies; resolving discrepancies or returning incomplete documents to the team leader for resolution
  • Enters submission data per requirements of client regulatory digital platform (i.e. eMAP, Veeva, Zinc)
  • Verifies entered data by reviewing, correcting, deleting, or reentering data
  • Follows submissions through the system and keeps teams updated with approval progress
  • Stays up to date on training and platform updates
  • Maintains agency and client confidence and protects operations by keeping information confidential
  • Assures that document management strategies and regulatory requirements for documents are upheld
  • Attends company-sponsored in-services and/or continuing education
  • Participates in professional development activities and maintains professional affiliations as necessary
  • Performs other job duties as assigned

Interested in the job? Let’s talk. Send your resume and any supplemental materials you deem appropriate to asjobs@2ecreative.com.