Senior Safety Compliance Officer conducting safety evaluations and investigations for employers under Oregon OSHA. Ensuring compliance and providing training and assistance in workplace safety issues.
About the role
- Lead digital and physical regulatory records management for a global health care leader. Overseeing archival operations and ensuring compliance within Regulatory Affairs & Clinical Safety.
Responsibilities
- Support the BSO for the Veeva Vault RIM Submissions Archive, providing support to system development, maintenance, enhancements, and monitoring.
- Liaise with IT, Learning & Development, and global stakeholders to define and implement user requirements, workflows, and metadata standards.
- Ensure compliance with global regulatory standards and internal SOPs for electronic submissions and correspondence.
- Collaborate with publishing, registration, and planning teams to maintain alignment across the regulatory lifecycle.
- Oversee the central archive team, including offshore contractors and temporary onshore staff.
- Manage archival activities related to acquisitions, divestitures, audits, litigation, and regulatory inquiries.
- Ensure accuracy, throughput, and quality of archival work, including budget oversight for temporary staffing.
- Coordinate with Business Development Execution teams and system owners of related platforms (e.g., eTMF) for migration and record alignment.
- Support GRACS’ long-term strategy to unify regulatory platforms under Veeva RIM, ensuring cross-functional coordination and system interoperability.
- Represent the archive function in strategic planning meetings, system integration workshops, and change management initiatives.
- Advocate for continuous improvement in archival processes, leveraging analytics and stakeholder feedback.
Requirements
- Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas or a minimum of 12+ years of industry experience, at least 6 of those in a regulatory/compliance industry utilizing records/document management systems.
- Direct experience in Veeva RIM Submissions Archive.
- Proven leadership in managing both digital systems and physical archives.
- Strong understanding of regulatory submission types (eCTD, IND, NDA, ANDA) and Health Authority requirements.
- Knowledge of system development lifecycle, data/content administration concepts, and capabilities applying technology within a business environment.
- Experience supporting and working with tools and systems used in a regulatory/compliance environment, including managing archival collection or distribution for acquisitions, divestitures, litigations, audits, regulatory inquiries, and ad hoc work.
- Deep knowledge of managing records related to submissions content, health authority correspondences, and other regulatory documents.
- Demonstrated capabilities managing and mentoring staff, including managing onshore and offshore vendors for records management and related activities.
- Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting relationship.
- Demonstrated collaborative skills and ability to work in cross-functional and international environments.
- Excellent communication, stakeholder engagement, and project management skills.
- Advanced English skills.
Benefits
- Flexible Work Arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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