Audit & Compliance Specialist - Health Sciences
Hiring Company Name Job ID256465 DivisionHealth Science Global Business Unit Company TypeLarge Company, International Company Job TypeFull-time LocationTokyo - 23 Wards, Minato-ku Train DescriptionGinza Line, Gaien Mae Station Salary6 million yen ~ 9 million yen Date RefreshedToday Minimum Experience LevelOver 6 years Career LevelMid Career Minimum English LevelBusiness Level Minimum Japanese LevelFluent Minimum Education LevelBachelor's Degree Visa StatusJapanese national or permission to work in Japan required 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.
0 comments:
Post a Comment