Compliance and Quality Specialist
Il y a 2 mois
Join us to grow your expertise in an industry with ever evolving guidelines and standards.
**What You’ll Do**:
- Maintain quality standards within Oracle Life Sciences
- Assist in carrying out quality and documentation checks of study folders (e.g. internal audits).
- Review research study materials to ensure compliance with procedures, industry code of conduct (ESOMAR/ EphMRA/BHBIA), data privacy laws (GDPR), and quality standards.
- Interact with global research consulting teams to assess study requirements.
- Assist with administrative tasks
- Create and maintain dashboards to track queries.
- Maintain employee database: update database for leavers/joiners, categorize and file trainings in database.
- Support the Compliance and Quality team to deliver on KPI's as agreed with Senior Management
- Collaborate within the Compliance and Quality team to deliver and track trainings with internal and external stakeholders.Contribute as necessary to maintain audit readiness (ISO Certification, Client, Pharmacovigilance, vendor audits) Undergraduate degree in administration, clinical / academic / laboratory research, quality, pharmacy or other relevant fields.**What you’ll bring**
- Previous experience in market research, healthcare, quality assurance or quality control desirable
- Effective communicator: fluent in English with skillset to assess the target audience to adapt language and vocabulary accordingly
- Organized: diligent with eye for detail and ability to follow procedures
- Dynamic and flexible: capable of multi-tasking to prioritize under challenging deadlines
- Quick learner: attentive listener with capacity to quickly grasp different concepts to put into practice for studies with constantly evolving specifications
- Team player: willingness to collaborate closely within the core team and across multiple teams within the global research consulting organizationExcellent IT skills (Pack Office)
Career Level - IC1
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s problems. True innovation starts with diverse perspectives and various abilities and backgrounds.
When everyone’s voice is heard, we’re inspired to go beyond what’s been done before. It’s why we’re committed to expanding our inclusive workforce that promotes diverse insights and perspectives.
We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling +1 888 404 2494, option one.
**Disclaimer**:
Oracle is an Equal Employment Opportunity Employer*. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
** Which includes being a United States Affirmative Action Employer**
Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and suggests recommendations for changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies with some guidance based on complexity. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. Respond to security and/or compliance related requests and RFPs. Update and maintain internal and externally facing security documentation. Facilitate 3rd party audit activities. Maintain and track required compliance and security training for the GBUS. Maintain and update security and compliance reporting. Facilitate vendor security assessments as needed. Assist in managing security and/or quality, and compliance related projects for the GBUs.
Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and suggests recommendations for changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies with some guidance based
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