Principal Technical Writer

Purpose of Position:

The Principal Technical Writer is responsible for originating and reviewing analytical documentation in accordance with SOPs in support of analytical deliverables across multiple projects. Documentation includes but is not limited to method development/validation protocols and reports, test methods, and SOPs. This role serves as liaison across departments to ensure alignment and approval of documentation.

Key Responsibilities:

• Originate, revise and review technical documents in accordance with established procedures to present analytical information clearly and concisely.
• Review analytical data and reported results for completeness and accurately transfer technical information into written format using tables, graphs, text, or other means to present data and results clearly and completely.
• Liaison between AD staff and project stakeholders to ensure documentation is in scope and delivered within agreed-upon timelines.
• Coordinate documentation review with the Quality Unit to ensure documents meet established procedures and present technical information to the satisfaction of the clients and all stakeholders.
• Assist AD management in continuous improvement activities related to documentation, such as development of document templates and improved review workflow.

Job Experience and Knowledge Required:

• Bachelor’s degree in a Scientific Field or Technical Writing, and 8+ years of relevant experience.
• Understanding of the current regulatory requirements for analytical testing documentation (ICH, USP, FDA) and cGMP laboratory systems for commercial pharmaceutical applications.
• Proficient and knowledgeable in analytical chemistry techniques including HPLC and MS. Understanding of analytical chemistry documentation with the ability to generally interpret and accurately present laboratory data and results.
• Excellent technical writing skills and command of the English language.

Equal Opportunity Employer