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.