Job Description

*This position is 20-30 hours/week*

POSITION SUMMARY

The GCP SOP Writer is responsible for drafting, editing, and performing quality control review of Clinical Operations procedures. The role involves creating and revising key documents such as SOPs, Work Instructions (WIs), and other associated documents.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Write and edit SOPs and other documents across Clinical Development Operations
• Gather information from stakeholders and recommend shared practices
• Ensure SOPs are user-friendly and provide clear guidance
• Develop new SOPs or revise current ones to ensure compliance with GCP guidelines and internal standards
• Write clear and concise SOPs for day-to-day operations
• Collaborate with cross-functional teams to identify process improvements
• Model core values: Passion, Integrity, Innovation, and Patient Focus

REQUIREMENTS

Education

• BS/BA degree or equivalent required

Experience & Skills

• Minimum 8 years of experience in biotechnology/pharmaceutical companies; SOP writing for start-ups a plus
• At least 5 years’ experience in developing and editing GxP SOPs, including 3 years in Clinical SOPs
• Understanding of GCP guidelines and regulatory requirements (e.g., FDA, EMA)
• Effective organizational skills and attention to detail
• Ability to manage multiple tasks and changing priorities
• Local or remote candidates accepted
• Excellent writing, editing, and communication skills
• Strong interpersonal, problem-solving, organizational, and planning skills
• Proficiency in Microsoft Word, Excel, etc.

Job Tags

Similar Jobs