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Senior Associate

Senior Associate

CompanyZoetis
LocationParsippany-Troy Hills, NJ, USA, Kalamazoo, MI, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s, Master’s
Experience LevelMid Level, Senior

Requirements

  • BS/MS with 3 to 5 years of experience in a scientific discipline.
  • Ability to interpret regulations and to leverage them into favorable strategies for promotion of biological and pharmaceutical products and compliance.
  • Proven interpersonal/communication skills are essential, as these are required to influence positive outcomes with regulators and colleagues on teams.
  • Fully versed in Microsoft Office platforms, including Word, Outlook and PowerPoint.

Responsibilities

  • Assist in the review of A&P materials (e.g., brochures, digital ads, social media posts, websites, sales aids) to ensure compliance with FDA and USDA regulations, including 21 CFR Part 202, 9 CFR, and other applicable guidelines.
  • Ensure that promotional content adheres to regulatory standards, including fair balance, avoidance of misleading claims, and proper presentation of risk information.
  • Collaborate with senior reviewers to identify and address compliance issues.
  • Collaborate with Legal, Corporate Communications, Global Commercial Development, U.S. Operations, Business Technology, and VMRD colleagues to ensure that promotional boundaries and possibilities of product profile messaging are understood within the framework of current USDA/CVB and FDA/CVM interpretation and enforcement.
  • Prepare FDA product A&P materials for submission to FDA. Work with commercial teams and regulatory submission publishing teams to coordinate submission.
  • Stay updated on changes to FDA regulations and industry best practices related to advertising and promotion.
  • Assist in training across Zoetis regarding actions of USDA/CVB and FDA/CVM that may impact U.S. Operations business opportunities.

Preferred Qualifications

  • Experience in the animal health product industry with a strong scientific background in biological and pharmaceutical products is desirable.
  • Understanding of the 9 and 21 Code of Federal Regulations for animal products for advertising and promotion materials is desired.
  • Experience with Veeva Vault is desirable.