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Technical Policy Writer
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Robert Half
Fall River, MA (In Person)
Full-Time
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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.
Responsibilities:
- 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.