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Clinical Document Manager

Clinical Document Manager

Hybrid

London, United kingdom

Freelance

06-05-2025

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Job Specifications

Job Title: Signatory Specialist Business Partner

About the Role:
We are seeking a detail-oriented and experienced Signatory Specialist Business Partner for one of our Top Pharma Client. In this critical role, you will author, review, and manage the production of high-quality clinical and safety documents, ensuring compliance with both internal standards and external regulatory requirements. You will serve as a key contributor to clinical trial and safety management teams, offering expert guidance on documentation strategy and regulatory best practices.

Key Responsibilities:
Prepare and review essential regulatory documents such as clinical study reports (CSRs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs)
Participate as a core member in Clinical Trial Teams (CTTs) and Safety Management Teams (SMTs)
Provide expert consultation on document planning, data analysis presentation, and content compliance
Ensure documentation aligns with regulatory standards and company guidelines
May serve as Program Writer to coordinate medical writing resources and ensure consistency across program deliverables
Respond promptly to technical complaints, adverse events, or special case scenarios within 24 hours
Manage distribution of marketing samples, where applicable

Key Performance Indicators:
Timely delivery of high-quality, compliant documentation
Positive feedback from stakeholders and cross-functional teams
Adherence to company policies and regulatory guidelines

Ideal Candidate Profile:
Demonstrated expertise in clinical research, medical writing, and safety documentation
Strong understanding of regulatory compliance and clinical trial processes
Proven experience in cross-functional collaboration and working across global teams
Highly detail-oriented with excellent communication and organizational skills
Ability to work effectively in a fast-paced, deadline-driven environment

Preferred Experience & Skills:
Background in clinical operations or regulatory affairs
Experience managing multiple complex documentation projects
Familiarity with regulatory platforms and medical writing software
Cross-cultural or global team experience is an advantage

Join us to play a vital role in shaping clinical documentation excellence and contributing to the advancement of healthcare solutions worldwide.

About the Company

SRG are industry leaders in Life Sciences, Clinical and Engineering Recruitment and the largest Life Science recruitment agency in the UK. With over 30 years’ experience of helping leading STEM organisations find, hire and retain the very best STEM talent, we understand what job seekers and employers are looking to achieve, and what they need to get there. At SRG, our industry experts draw on their own experience, technical and scientific backgrounds and expertise, and work in partnership with businesses to ensure hiring su... Know more