Job Description

A Regulatory Compliance Consultant supports Oracle Life Sciences Global ISO certifications; as well as: Adherence to pharmacovigilance (adverse event reporting), data privacy (state and federal level), industry (GCP, GEP, GPP and GVP), internal (vendor management and training), pharmaceutical clients, and other regulatory (FDA and HIPAA) requirements. This position will report to the Senior Global Quality and Compliance Manager.

Career Level - N/A

Responsibilities

• Responsible for implementing established quality processes & ensuring adequate application among Asia/Pacific teams

• Responsible for ensuring that all projects are conducted in accordance with Oracle Life Sciences SOPs

• Perform internal and external auditing based on Oracle Life Science’s quality system standards; for example, ISO 9001:2015, ISO 20252:2019, PV, FDA readiness audits

• Responsible for ensuring compliance with pharmacovigilance requirements

• Communicate team, or domain level, goals that support and advance team, domain level, and/or organizational compliance objectives; monitor metrics, or other performance measures, to track progress against established goals

• Influence diverse stakeholder groups and drive acceptance of policies, practices and procedures within broader area of responsibility

• Identify, propose, and support team- and domain level, quality and process improvement initiatives; lead or influence strategic initiatives at the domain level and provide input on strategic initiatives for the organization

• Assist with training, guidance and feedback to encourage success and promote associate growth through regular domain developmental conversations and identification of domain developmental opportunities

• Maintain quality and compliance documentation- e.g. SOPs, templates, working instructions

• Organize and deliver trainings from clients and/or industry guideline trainings internally to Associates and externally to our vendors

About Us

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.

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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