Regulatory Document Specialist- Sponsor dedicated

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Job Purpose

Support internal and external customers and promote best documentation practice to ensure efficient an appropriate management of submission-relevant paper and electronic clinical documentation to meet regulatory requirements for submission to Health Authorities and be inspection ready.

Major Activities/Accountabilities

Perform formal/technical quality checks of Clinical Submission documents and related templates.

Oversee vendor services for Technical Document Quality Checks:

• Collaborate with external partner’s regional coordinators on daily operational activities
• Maintain documentation of appropriate oversight of all external partner’s work specific to document management
• Monitor and assess weekly status reports created by vendor based on Novartis’s input requirements
• Develop and recommend risk management, contingency plans and corrective or preventative actions to improve quality and compliance
• Train and monitor external partners supporting individual Document QC tasks

Define formal document standards in collaboration with business functions. Ensure adherence to standards for the management and technical quality review of clinical submission documents (Clinical Study Report, Clinical Trial Protocols, Investigator Brochures, Safety Reports, etc.), act as first line governance for any quality-related topics.

Drive improvements and innovation on business and technical aspects of clinical submission document processing and technical QC. Ensure quality, timelines, and efficiency and Good Documentation Practice standards.

Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs.

Establish and maintain sound working relationships with partners/business functions and customers

Support Document Managers in ensuring appropriate and accurate document creation and document lifecycle management in the Document Management System (DMS), by activities such as User Requirement review, system testing or training material creation.

Key Performance Indicators

• Definition of quality standards for documents and document processing
• Efficient production of deliverables 
• No critical findings from audits/inspections
• Effective turnover of improvements and innovation for formal document QCs and Clinical Template Management
• Registration documents meet internal and external quality standards for HA submissions

Experience/Professional requirement:

• College degree or equivalent education in life science/healthcare or related scientific discipline (natural, pharmaceutical, medical, archival or information technology).                            
• At least 3 years of relevant experiences in managing, archiving, retrieving or compiling clinical documents
• At least 4 years of relevant clinical research/pharmaceutical industry experiences
• Knowledge of the clinical drug development and international drug approval processes and related document requirements
• Expert knowledge of PDF tools and advanced Word functionality of advantage
• Good organizational skills and project work or project management experience
• Experience with working remotely with global teams
• Fluent English (oral and written)

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.