This role can be based in any European Country.

Overview of the Organization

The Oracle Health Sciences GBU (Global Business Unit) provides industry leading solution to life sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), academic research and healthcare providers.  The portfolio of Oracle Health Sciences includes cloud and/or on-premise solutions for eClincal (eCRF, RTSM, CTMS, Study Start-up, Clinical Analytics, and Clinical Warehousing), pharmacovigilance/device vigilance and signal detection, healthcare interoperability and enterprise healthcare analytics.  Oracle is leveraging AI/ML technologies to drive efficiencies in industry data management processes.

The Regulatory Compliance and Risk Management (R&C) function provides in-house expertise to service delivery, product development and product support functions on clinical and safety domain compliance. Additionally R&C manages the quality management system (QMS), assists sales activities and coordinates internal & customer audit programs.  R&C undertakes a range of compliance and risk management programs including HIPAA/HITECH assessments and actively monitors the external regulatory environments whilst working with industry bodies to establish and promote best practices.
 
Role Description
The Oracle Health Sciences Risk & Compliance function is seeking to recruit a Senior Regulatory Compliance Specialist to assist the regulatory risk team with assessing the compliance requirements of new and evolving solutions and services, assessing and driving changes arising from both developments in the external regulatory environment and the provision of support to customers for regulatory inspections.
The successful candidate will be expected to interface with both senior management and the various delivery teams across Oracle Health Sciences to support customer inspection needs and to define and maintain our compliance posture in an environment of increasing cloud service growth, system integration and regulation.
 
Key Responsibilities
Responsibilities include\:

• Provide compliance assistance and support to customers and internal functions responding to regulatory agency inspection requests.  
• Supporting designated eClinical, safety and healthcare product development teams with regard to domain and computerised system validation (CSV) compliance requirements and expectations with particular consideration to compliance requirements for cloud implementations.
• Contribute to the maintenance of the Oracle Health Sciences Quality Management System (QMS) to comply with applicable requirements.
• Work with internal teams to implement process/product improvements based on outcome of audit observations.
• Assisting Risk & Compliance colleagues during internal / customer / supplier audits.  Contribute to the preparation of customer audit or other required responses.
• Provide education to Oracle Health Sciences and related line of business personnel on domain compliance requirements.
• Maintaining familiarisation with evolving industry and regulatory requirements particularly in the eClinical and safety domains.  Disseminate information about regulatory developments and educate Oracle Health Sciences accordingly.
• Provide input and guidance from a regulatory and quality perspective to Oracle Health Sciences lines of business to facilitate timely decision making related to product development, service delivery, product support and business development.

 
Preferred Qualifications 

• BS/BA Degree in scientific discipline or 10+ years of experience as a QA professional in a regulated pharmaceutical or device environment (preferably GCP).
• Experience is implementing/applying risk management programs within the GXP arena.
• Must have a sound knowledge of key relevant industry and government regulations (e.g. 21 CFR 11, ICH GCP R2, EU Annex 11, GPvP) in the clinical and/or safety domains, together with demonstrable practical experience of applying these to computerized systems in these domains.
• Awareness of key data privacy legislation (for example HIPAA/HITECH and/or EU GDPR) impacting the eClinical and Safety domains.
• Familiarity with computerized systems validation (CSV) approaches (e.g. GAMP5, FDA guidance on software validation) and practical experience applying such approaches to clinical or safety related systems.
• Practical hands-on experience with the preparation and conduct of regulatory GXP inspections essential
• Candidate must be a self-starter; who takes the initiative and has the ability to work independently and manage multiple projects/priorities.
• Superior communication skills (interpersonal, verbal, presentation written, email).
• Must have proven abilities in driving change within an organization.
• Must be methodical, well organized and detail oriented.  Individual must be readily adaptable to a fast-paced, multidisciplinary team-based environment.
• Ability to travel internationally as required.
• Experience in conducting supplier and internal audits of computerized systems and/or software/cloud suppliers beneficial.
• Practical experience with Oracle Health Sciences eClinical or Safety products desirable.

 
Position Location\: UK/EU/EEA
Travel Component\: Approx. 5-10%