Job Description 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 sa...