GCP SOP Author

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are, and push the boundaries of social responsibilities. We are now seeking a GCP SOP Author to join our amazing team. 

Job Title: GCP SOP Author 

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview: 

We are seeking a talented and experienced freelance GCP SOP (Standard Operating Procedure) Author to join our team. The ideal candidate will have a thorough understanding of Good Clinical Practice guidelines and regulatory requirements about clinical trials. As a freelance SOP Author, you will be responsible for developing, reviewing, and updating Standard Operating Procedures related to clinical trial conduct, ensuring compliance with GCP standards and industry best practices.

Responsibilities:

• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, quality assurance, and medical affairs, to identify SOP needs and requirements for clinical trial activities.
• Develop new SOPs or revise existing SOPs to ensure compliance with GCP guidelines, regulatory requirements (e.g., FDA, EMA), and internal quality standards.
• Conduct thorough literature reviews, regulatory research, and benchmarking exercises to gather relevant information and best practices for inclusion in SOPs.
• Write clear, concise, and comprehensive SOP documents that outline procedures, responsibilities, and requirements for clinical trial conduct, data management, and regulatory compliance.
• Ensure SOPs are written in accordance with company templates, formatting guidelines, and style conventions, and are consistent with other related documents and processes.
• Review and update SOPs on a regular basis to incorporate changes in regulations, industry standards, and internal processes, ensuring SOPs remain current and effective.
• Maintain a comprehensive SOP library, including version control, document management, and archiving procedures, to ensure accessibility and traceability of SOP documents.

Requirements:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in clinical research, regulatory affairs, or quality assurance roles within the pharmaceutical, biotechnology, or CRO industry, with a minimum of 5 years working directly with GCP guidelines and SOP development.
• In-depth knowledge of GCP regulations (e.g., ICH E6), FDA regulations (21 CFR Part 50, 56), and other relevant guidelines governing clinical trial conduct.
• Proven experience in writing, reviewing, and revising SOPs, work instructions, or related documents in a regulated environment.
• Strong writing and communication skills, with the ability to convey complex information clearly and effectively to diverse audiences.