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