Technical Writer Specialist

Mentor Technical Group (MTG) is a leader in technical support and solutions for the FDA-regulated industry. They serve life sciences clients globally and are seeking a Technical Writer Specialist to author, revise, and maintain SOPs and related controlled documents in accordance with regulatory and company standards. The role involves collaboration with cross-functional teams to ensure documentation reflects current practices and supports internal and external audits.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field.
• 2–5 years in a regulated industry (pharma, biotech, medical devices) with direct experience in SOP writing or quality documentation.
• Knowledge of regulations such as FDA 21 CFR Part 11, ISO 13485, ICH Q10, and GxP principles.
• Proficiency in EDMS (e.g., Veeva, CDOCS, Kneat, AML, MasterControl, Documentum).
• Strong writing and editing skills, with the ability to translate complex processes into clear instructions.
• Attention to detail and strong organizational skills.
• Excellent communication and interpersonal skills for cross-functionality.

Benefits

• Equal opportunity employer