Technical Procedure Writer

Job Summary

This Technical Procedure Writer position within Quality and Compliance is responsible for supporting clients development, updates, reviews, and approvals of Quality Documents, such as Policies, Procedures, and Work Instructions.

Responsibilities

• Manage the controlled document approval process (author, review, approval).
• Assist project teams in updating global and local controlled documents.
• Manage high volume of document updates from multiple regions and projects.
• Identify the procedures that need to be updated due to planned process changes.
• Coordinate procedure editing and review activities across global sites.
• Assist document authors with alternative wording, presentation, and style to ensure clarity of content.
• Assist project teams with harmonizing document update feedback from multiple reviewers.
• Edit draft procedural documents to ensure the technical material is clear, concise, and effective to global users.

Necessary Skills and Abilities

• 3+ years of experience in technical writing, specializing in Standard Operating Procedures (SOPs) and Work Instructions for the Pharmaceutical industry.
• 3+ years of experience processing documents through the entire document life cycle, including Change Requests, red-lining, stakeholder review, submission for approvals, and retirement.
• Excellent written and spoken English.
• Experience using electronic document management systems; Veeva experience is a plus.
• Highly proficient in MS Office products, such as Word, PowerPoint, and Excel.
• Expertise in SOP writing techniques.
• Ability to work effectively with remote team members across different time zones.
• Able to work flexible hours when needed to accommodate global project teams.
• Able to work effectively with other professionals, such as Quality Assurance specialists, pharmacovigilance specialists, and information technology specialists.
• Ability to work independently with minimal supervision.
• Ability to work on multiple simultaneous projects with tight deadlines.
• Excellent organizational skills and attention to detail.

Educational Requirements

• AS or BS degree in a related field.

Experience Requirements

• 3+ years of experience in technical writing, specializing in Standard Operating Procedures (SOPs) and Work Instructions for the Pharmaceutical industry, including:

• Experience with the entire documentation development life cycle from procedure design, authoring, and approval workflow management.
• Basic knowledge of GMP, GCP, and GPvP processes is a plus.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.