Clinical SOP and Process Documentation Consultant
- UK
- Quality Assurance
- ICON Strategic Solutions
Talent Acquisition Team Lead
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
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
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish date
02/28/2022
Summary
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
Teaser label
Inside ICONContent type
BlogsPublish date
01/28/2015
Summary
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
Similar jobs at ICON
Salary
Location
Netherlands, Assen
Department
Full Service - Quality Assurance
Location
Assen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Quality Assurance
Job Type
Permanent
Description
The Early Development Services (EDS) division of ICON is a global leader in providing early-phase clinical research (phase I and IIa) and bioanalytical services to the pharmaceutical and biotechnology
Reference
JR140685
Expiry date
01/01/0001
Author
Jonathan CunliffeAuthor
Jonathan CunliffeSalary
Location
US, Blue Bell (ICON)
Location
Blue Bell
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Quality Assurance
Job Type
Permanent
Description
We are currently seeking a CAPA Manager to join our diverse and dynamic team. As a CAPA Manager at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex m
Reference
JR138668
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
China, Beijing
Location
Beijing
Remote Working
Office or Home
Business Area
ICON Strategic Solutions
Job Categories
Clinical Quality Assurance
Job Type
Permanent
Description
We are currently seeking a Clinical Quality Compliance Specialist to join our diverse and dynamic team. As a Clinical Quality Compliance Specialist at ICON, you will play a pivotal role in designing a
Reference
JR138538
Expiry date
01/01/0001
Salary
Location
Malaysia, Kuala Lumpur
Location
Kuala Lumpur
Remote Working
Office or Home
Business Area
ICON Strategic Solutions
Job Categories
Clinical Quality Assurance
Job Type
Permanent
Description
We are currently seeking a Clinical Quality Compliance Specialist to join our diverse and dynamic team. As a Clinical Quality Compliance Specialist at ICON, you will play a pivotal role in designing a
Reference
JR138923
Expiry date
01/01/0001
Author
Leslie GarciaAuthor
Leslie GarciaSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Dublin
Blue Bell
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Quality Assurance
Job Type
Permanent
Description
We are currently seeking a Clinical Quality Compliance Lead to join our diverse and dynamic team. As a Clinical Quality Compliance Lead at ICON, you will play a pivotal role in designing and analyzing
Reference
JR136890
Expiry date
01/01/0001
Author
Sasha BrownAuthor
Sasha BrownSalary
Location
Argentina, Buenos Aires
Location
Buenos Aires
Remote Working
Office or Home
Business Area
ICON Strategic Solutions
Job Categories
Clinical Quality Assurance
Job Type
Permanent
Description
We are currently seeking a Clinical Quality Compliance Lead to join our diverse and dynamic team. As a Clinical Quality Compliance Lead at ICON, you will play a pivotal role in designing and analyzing
Reference
JR138659
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio Sanquiz