Senior Regulatory Compliance Specialist, Oracle Health Sciences-19000ALNNo Visa Sponsorship is available for this position.
Preferred Qualifications Overview of the Organization
OracleHealth Sciences Global Business Unit (GBU) provides industry leading solutionto life sciences organizations including pharmaceutical companies, CROs(Contract research Organizations), academic research and healthcareproviders. The portfolio of OracleHealth Sciences includes cloud and/or on premise solutions for eClincal (eCRF,RTSM, CTMS, Clinical Analytics, and Clinical Warehousing),pharmacovigilance/device vigilance and signal detection, healthcareinteroperability, enterprise healthcare analytics and Translational Research.
TheRegulatory Compliance and Risk Management (R&C) function provides in-houseexpertise to service delivery, product development and product supportfunctions on clinical and safety domain compliance. Additionally R&C managesthe quality management system (QMS), assists sales activities and coordinatesinternal & customer audit programs. R&C undertakes a range of compliance and risk management programsincluding HIPAA/HITECH assessments and actively monitors the external regulatoryenvironments whilst working with industry bodies to establish and promote bestpractices. Role
The OracleHealth Sciences Risk & Compliance function is seeking to recruit a SeniorRegulatory Compliance Specialist to assist the regulatory risk team withassessing the compliance requirements of new and evolving solutions andservices, assessing and driving changes arising from both developments in theexternal regulatory environment and mitigation activities arising from internalrisk management programs.
Thesuccessful candidate will be expected to interface with both senior managementand the various delivery teams across Oracle Health Sciences to define andmaintain our compliance posture in an environment of increasing cloud service growth,system integration and digital/mobile health adoption. Key Responsibilities Supportingdesignated eClinical, safety and healthcare product development teams withregard to domain and computerized system validation (CSV) compliancerequirements and expectations with particular consideration to compliancerequirements for cloud implementations. Contributeto the maintenance of the Oracle Health Sciences Quality Management System(QMS) to comply with applicable requirements. Oversight ofthe Oracle Health Sciences risk management program in accordance with corporatepolicies and liaison, as necessary, with other Oracle lines of business. Work withinternal teams to implement process/product improvements based on outcome ofaudit observations. AssistingRisk & Compliance colleagues during internal / customer / supplier auditsor regulatory inspections. Contributionto the preparation of customer audit or other required responses. Provideeducation to Oracle Health Sciences and related line of business personnel ondomain compliance requirements. Assistin development and roll-out of necessary training collateral. Maintaining familiarizationwith evolving industry and regulatory requirements particularly in theeClinical and safety domains. Disseminate information about regulatory developments and educate OracleHealth Sciences accordingly. Provideinput and guidance from a regulatory and quality perspective to Oracle HealthSciences lines of business to facilitate decision making related to productdevelopment, service delivery, product support and business development. Preferred Qualifications BS/BA Degreein scientific discipline or 10 years of experience as a QA professional in aregulated pharmaceutical or device environment (preferably GCP). Experience inimplementing/applying risk management programs within the GXP arena. Must have asound knowledge of relevant industry and government regulations (e.g. 21 CFR11, ICH GCP R2, GPvP) in the clinical and/or safety domains, together withdemonstrable practical experience of applying these to computerized systems inthese domains. Detailedfamiliarity with computerized systems validation (CSV) approaches (e.g. GAMP5,FDA guidance on software validation) and practical experience applying suchapproaches to clinical or safety related systems. Candidatemust be a self-starter; who takes the initiative, and have the ability to workindependently and manage multiple projects/priorities. Must haveexperience in the development, and maintenance of quality management system. Superiorcommunication skills (interpersonal, verbal, presentation written, email). Must haveproven abilities in driving change within an organization. Must bemethodical, well organized and detail oriented. Individual must be readily adaptable to a fast-paced, multidisciplinaryteam-based environment. Ability totravel internationally as required. Experiencein conducting supplier and internal audits of computerized systems and/orsoftware/cloud suppliers beneficial. Practicalexperience with the preparation and conduct of regulatory GXP inspectionsadvantageous. Practicalexperience with Oracle Health Sciences InForm, IRT, CRF Submit, Argus productsdesirable. Familiaritywith the application of HIPAA/HITECH and/or EU GDPR requirements to GXPenvironments also of benefit. Position
Associated topics: aseptic, aseptic technique, biopharmaceutical, drug discovery, health, immunology, injury, pharmacometrics, protein, trauma