Job Description

Technical Writer

Clayton, NC

We are seeking an experienced Technical Writer/Procedure Documentation Specialist to partner with colleagues, customers, and stakeholders on initiatives focused on process optimization and continuous improvement within the Technical Writing Group. This role will primarily focus on developing procedural documentation within a GxP-regulated environment, ensuring regulatory compliance and operational efficiency, while also creating training materials and job aids.

Key Responsibilities:

• Lead cross-functional teams of subject matter experts, business process owners, and stakeholders in the creation, revision, improvement, implementation, and ongoing maintenance of process and procedural documentation.
• Plan, coordinate, and oversee multiple process development projects concurrently, ensuring the successful and timely completion of project objectives.
• Develop and author training program content, including clear and effective training materials and job aids that support process comprehension and practical application.
• Apply knowledge of global regulations within a GxP environment to develop processes and supporting documentation that meet regulatory standards, support corporate compliance, and remain inspection-ready.
• Support compliance initiatives and audit/inspection readiness strategies to ensure all documentation aligns with required regulatory and organizational standards.
• Review and assess global procedural documentation in relation to evolving regulatory expectations, industry standards, audit/inspection outcomes, and internal policies; recommend updates and improvements based on insights, feedback, and best practices.

Qualifications:

• Education: Minimum of a BA or BS required; an advanced degree in a related field is preferred. A degree or professional certification in process design or change management is a plus.

Experience:

• Minimum of 3+ years of experience in pharmaceutical business process design, documentation, and change management required.
• Experience developing, delivering, and/or implementing process training is preferred, including creating training materials and job aids.
• Experience working within a GxP-regulated environment is required.
• Project Management Skills: Demonstrated ability to manage multiple projects simultaneously; PMP certification is a plus.
• Technical Writing: Experience in pharmaceutical technical writing, particularly the development of Standard Operating Procedures (SOPs), is required.
• Organizational Skills: Strong planning, organization, and multitasking capabilities with the ability to prioritize multiple assignments and meet tight deadlines.
• Adaptability: Ability to perform effectively in fast-paced environments and adapt to changing priorities while maintaining strong attention to detail.
• Technical Proficiency: Skilled in standard desktop tools including MS Word, MS Excel, MS Project, Visio, and PowerPoint. Experience with SharePoint, MS Teams, and Forms is a plus.
• Communication Skills: Excellent verbal and written communication skills with a strong understanding of pharmaceutical business processes, regulations, guidelines, and industry compliance standards.

Critical Skills/Experience

1. Experience working in a GxP-regulated environment
2. Strong project management capabilities with proven experience managing multiple projects simultaneously; PMP certification is a plus
3. Experience in pharmaceutical technical writing, particularly developing Standard Operating Procedures (SOPs)
4. Ability to develop training materials and job aids that support process understanding and effective implementation
5. Proficiency with Visio for creating process maps and workflow diagrams
6. Ability to contribute to high-priority initiatives under pressure while maintaining strong attention to detail

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