Director, Regulatory Affairs – Regulatory Science and Execution
AstraZeneca
Compliance and Risk Management Specialist
Organon
full-time
Posted on:
Location Type: Hybrid
Location: 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Manage the change management to ensure compliance
- Ensure that the SOX ITGC Controls were identified and addressed for the deployment / update, working in partnership with other ESQ&C areas
- Perform risk assessments and identify key ITGCs related to access management, change management, and IT operations
- Assist in the design, implementation, and documentation of IT controls
- Collaborate with control owners to remediate deficiencies and improve control effectiveness
- Support internal and external audit teams during SOX audits
- Monitor changes in IT systems and processes that may impact SOX compliance
- Provide training and guidance on SOX compliance requirements
- Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective
Requirements
- Bachelor's degree
- Preferably Information Systems, Computer Science, Accounting or equivalent
- Preferable Professional certifications such as CSOPTM or equivalent
- Fluent English Speaker
- Hands-on experience and understanding of systems supporting pharmaceutical companies
- At least 3 years of experience IT audit, SOX 404 compliance, or IT risk management
- Familiarity with frameworks such as COBIT, NIST, or ISO 27001
- Strong understanding of ITGCs and their role in financial reporting
- Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations
- Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance
- Familiarity or practical experience in the implementation of systems in a pharmaceutical company
- Limited supervision required in day-to-day activities
- Excellent analytical, communication, and documentation skills
Benefits
- Flexible Work Arrangements: Hybrid
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ITGCsSOX complianceIT auditrisk managementcomputerized system validationchange managementaccess managementcontrol effectivenessaudit supportdocumentation
Soft skills
analytical skillscommunication skillsdocumentation skillscollaborationtrainingguidanceproblem-solvingattention to detailindependenceorganizational skills
Certifications
Bachelor's degreeCSOPTMequivalent certifications
