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Technical Policy Writer

United States, Somerset · Job Posted May 26, 2026
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Job Description

We are looking for a Technical Policy Writer to support documentation efforts for a biopharma manufacturing environment in Somerset, New Jersey. This is a Contract position that will focus on developing and refining controlled procedures for a new laboratory operation while partnering closely with subject matter experts across the site. The ideal candidate brings strong technical writing experience, a solid understanding of regulated laboratory practices, and the ability to produce clear, compliant documentation in a fully on-site setting.

Job Responsibility

  • Create, revise, and organize standard operating procedures and related controlled documents for laboratory start-up and ongoing operations
  • Partner with scientists, quality personnel, and other stakeholders to gather technical details and translate them into accurate, user-friendly documentation
  • Ensure written procedures align with Good Laboratory Practice expectations and applicable regulatory standards, including 21 CFR Part 58 requirements
  • Review existing content for clarity, consistency, and compliance, making updates where needed to support operational readiness
  • Manage document workflows and version control within established quality systems, including MasterControl when applicable
  • Facilitate discussions with cross-functional teams to confirm process details, resolve documentation gaps, and maintain approval timelines
  • Support on-site documentation needs five days per week while helping maintain a consistent format and writing standard across procedures

Requirements

  • At least 3 years of experience in technical writing within a regulated industry, preferably biopharma, pharmaceutical, or laboratory operations
  • Demonstrated success developing SOPs, work instructions, or controlled documents in a compliance-driven environment
  • Working knowledge of Good Laboratory Practices and familiarity with 21 CFR Part 58
  • Strong communication skills with the ability to interview stakeholders and convert complex processes into clear written procedures
  • Experience managing document review cycles and maintaining accuracy in revision-controlled systems
  • Availability to work on-site in Somerset, New Jersey five days per week

Nice to have

Familiarity with MasterControl or similar electronic document management software is preferred

What we offer

  • Medical, vision, dental, and life and disability insurance
  • Company 401(k) plan
  • Free online training

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