FDA Junior Paralegal

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:

Qualifications

• 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.