FDA Junior Paralegal

FDA Junior Paralegal

FDA Junior Paralegal




Employment Type



$1 - $2

Job Description:

Responsibilities & Duties

  • Review ingredients, formulas, amount, packaging, etc. for drug listings for submission to vendor and updates to the client with final drug listing;
  • Research medical device claims;
  • Draft and submit requests for information;
  • Draft and edit 513(g) letters;
  • Review 21 CFR requirements for labels and provide Comment advice following CFT guidelines;
  • Assess health and marketing claims for products;
  • Assess and track marketing reviews made online (including websites and company social media accounts);
  • Draft and submit FOIA requests to FDA FOIA office;
  • Track FOIA requests and analyze documents received in response to the same;
  • Research FDA-related documents, 501ks, product registrations, due diligence reports, federal and state regulations, health claims, industry articles, ingredient tests/studies, recall letters, litigation dockets;
  • Review and summarize health studies;
  • Review of Industry News for preparation of daily/weekly industry updates;
  • Drafting client-facing industry updates through the drafting and editing of blog posts and client alerts;
  • Prepare and revise presentations using PowerPoint, and conduct research for the same;
  • Track progress of projects through coordination of various professionals and the drafting of emails to clients regarding project status;
  • Draft and/or reviser opinions, agreements, engagements, memoranda, emails, due diligence reports, client alerts, etc.;
  • Coordinate and attend weekly FDA group project meeting;
  • Ability to handle sensitive matters and maintain confidentiality;
  • Committed to work outside of normal business hours as needed;
  • Meet the firm’s paralegal billable-hours requirement; and,
  • Assist with all other needs for project as requested.

Job Requirements:


  • The qualified candidate has at least one year of experience in a law firm setting, with preference to those having experience working with the Food and Drug Administration (FDA);
  • Familiarity with filing letters, responding to agency requests, and preparing documents for agency submission (consideration will be given to a candidate with similar experience before entities such as the Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), or State Attorney General);
  • Firm understanding of federal regulations, such as the CFR code or Federal Register notices. Experience working on corporate transactions and with data rooms preferred;
  • The successful candidate is detail-oriented;
  • Familiarity with Bloomberg, LexisNexis, MediRegs, PACER, PLI, etc.;
  • Exhibits sophisticated time and project management skills;
  • Has polished written and verbal communication skills;
  • Excels at managing deadlines, multiple work streams, and multiple supervisors;
  • Experience with Word, Excel, PowerPoint, and document management systems like iManage;
  • Experience with AAFCO pet food regulation is a plus;
  • Familiarity with The Bluebook, is a plus; and,
  • Candidates must hold a bachelor’s degree.