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.
Remember to check your CV before applying Also, ensure you read through all the requirements related to this role.
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.