Technical Policy Writer

• 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

• 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

Familiarity with MasterControl or similar electronic document management software is preferred

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