GCP SOP Writer

GCP SOP Writer – Contract (20–30 hours/week)

POSITION SUMMARY

The GCP SOP Writer is responsible for drafting, editing, and performing quality control reviews of Clinical Operations procedures. This role works closely with process owners, subject matter experts, and key stakeholders to develop, revise, and maintain Clinical Operations documentation. Responsibilities include the creation and updating of Standard Operating Procedures (SOPs), Work Instructions (WIs), and other associated documents.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide writing and editing support for SOPs and related documentation across the Clinical Development Operations function

• Gather information from internal stakeholders who currently perform operational processes and recommend standardized practices that balance consistency with varying team needs

• Ensure SOPs are written in a clear, user-friendly format that provides actionable guidance

• Develop new SOPs and revise existing SOPs to ensure compliance with GCP guidelines, internal quality standards, and inspection readiness expectations

• Produce clear, concise documentation to support day-to-day clinical operations in accordance with applicable regulations

• Collaborate cross-functionally to identify process improvement opportunities and recommend enhancements to efficiency and effectiveness

• Demonstrate professionalism, accountability, and a commitment to quality and patient-focused outcomes

REQUIREMENTS

Education

• Bachelor’s degree (BS/BA) or equivalent required

Experience & Skills

• Minimum of 8 years’ experience within a biotechnology or pharmaceutical organization; experience supporting a start-up environment is a plus

• At least 5 years of experience developing and editing GxP SOPs, including a minimum of 3 years focused on Clinical SOPs

• Strong understanding of GCP guidelines and regulatory requirements (e.g., FDA, EMA)

• Excellent writing, editing, and communication skills with strong attention to detail

• Ability to simplify complex processes into clear, usable documentation

• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment

• Demonstrated ability to collaborate effectively with cross-functional teams

• Solid understanding of process documentation standards and best practices

• Working knowledge of the drug development lifecycle, ICH/GCP guidelines, clinical trial operations, and medical terminology

• Self-motivated, proactive, and able to work independently

• Strong problem-solving, planning, and prioritization skills

• Proficiency with Microsoft Office tools (e.g., Word, Excel)

• Position may be local or fully remote