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Overview:

The Audit & Compliance (A & C) function provides quality oversight to the Oracle Health Sciences Global Business Unit (HSGBU) product development and service operations. The HSGBU supplies and supports a wide range of products in the life sciences and healthcare arena including applications for clinical data management and pharmacovigilance. As a result A & C personnel are actively involved in a range of activities to ensure that software development, consulting and customer support processes and deliverables meet the expectations of customers, regulatory bodies and management. In addition, the candidate in this role will participate in and conduct customer and supplier audits and will be expected to act as the subject matter expert for relevant domain regulations within the Japan market.

To provide regulatory guidance to internal staff and external customers with specific focus on clinical trial, data management and data protection/privacy requirements

To manage the planning, conduct and where applicable, reporting of customer/internal audits together with resolution of any findings identified

To support strategic goals by providing leadership and process expertise with regard to quality improvement initiatives

Identifying improvement opportunities within the Quality System and managing updates to relevant documents (e.g. Standard Operating Procedures) and training materials

To assist in supplier management programs through ongoing monitoring of the quality of supplier deliverables

To assist sales and marketing functions with regard to quality & compliance related issues and the completion of customer proposals

To assist delivery organisations through review and assessment of project deliverables

To prepare and deliver staff training courses on regulatory related subjects

Monitor developments in the regional regulatory environment and alert management to any possible business impact

To Investigate and support the remediation of customer complaints and incidents

As required to represent Oracle on external working parties / committees to reinforce industry leadership

A life science or computing degree or equivalent

Experience of clinical development preferably within a quality assurance role Alternatively specific clinical software development experience would be considered

Domain experience of the application of computer validation methodologies to clinical and/or drug / device safety systems

Experience of conducting internal and supplier audits (especially of software/hardware vendors)

Thorough knowledge of the key regulations and guidelines regarding clinical research and the use of computerized systems

An understanding of principles and practices of drug / device safety

Previous exposure to electronic data capture and data management technologies

Broad awareness of regional domain related data protection and privacy requirements

Demonstrable experience in process improvement and associated methodologies

Attention to detail with an organised and thorough approach to work

Strong and confident communicator fluent in written and verbal English

Oracle Corporation, the world's largest enterprise software company, specializes in developing and marketing enterprise software products — particularly database management systems. Through organic growth and through a number of high-profile acquisitions (PeopleSoft, Siebel, Agile, Hyperion, Demantra, Retek and others) Oracle enlarged its share of the software market. By 2007 Oracle ranked third on the list of largest software companies in the world, after Microsoft and IBM. Oracle subsequently surpassed IBM after its acquisition of Hyperion and of BEA.

The corporation has arguably become best-known due to association with its flagship Oracle database. Oracle also develops, manufactures, markets, distributes, and services database and middleware software as well as applications software designed to help customers manage business data, support business operations, and facilitate collaboration and application development and grow their business operations.

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