Clinical SOP and Process Documentation Consultant
- UK
- Quality Assurance
- ICON Strategic Solutions
Talent Acquisition Team Lead
- Icon Strategic Solutions
About the role
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Clinical SOP and Process Documentation Consultant
We are seeking an experienced Clinical SOP and Process Documentation Consultant to support the development and refinement of procedural documents aligned with business process maps and ICH E6(R3) guidelines. This role is critical in ensuring high-quality, inspection-ready documentation that supports the implementation of clinical insourcing model
Key Responsibilities:
- Translate mapped business processes into clear, structured Standard Operating Procedures (SOPs), Work Instructions, and supporting documentation.
- Ensure full alignment with ICH E6(R3), GCP, and internal standards.
- Collaborate with process owners and subject matter experts (SMEs) across clinical functions to accurately capture operational practices.
- Ensure consistent formatting, structure, and compliance using SOP templates and style guides.
- Maintain traceability between business process maps and written procedures.
- Minimize review cycles by adhering strictly to SOP authoring guidelines and quality expectations.
- Support document lifecycle management including revisions, version control, and archival.
Required Qualifications:
- Minimum 2-3 1years of experience writing SOPs and procedural documents in English within the life sciences or pharmaceutical industry.
- Proven expertise in interpreting complex business process maps and workflows.
- Strong command of MS Word, document formatting, and template management.
- Familiarity with ICH-GCP and especially ICH E6(R3) expectations.
- Detail-oriented, with excellent organizational and communication skills.
Experience working in cross-functional teams and within a regulated environment
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. Learn more about Our Culture at ICON
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02/28/2022
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Around 268,000 people are employed by the UK life sciences industry and as one of the fastest-growing sectors, this number is expected to continue rising. Life sciences is a flourishing job mark
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ICON began its journey to international success from humble beginnings in Ireland in 1990. Started by Dr John Climax and Dr Ronan Lambe, the first office had five team members and since then has
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