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Oracle Regulatory Compliance Specialist in Burlington, Massachusetts

Job Identification : 106951

Job Category : Business practice and Operations

Job Locations :

Burlington, Massachusetts, United States

United States

The Oracle Health Sciences GBU (Global Business Unit) provides industry leading solutions to life sciences organizations including pharmaceutical companies, academic researchers and CROs. The Oracle Health Sciences portfolio includes cloud and/or on-premise solutions for clinical data collection, RTSM, study start-up, trial management, pharmacovigilance/device vigilance and signal detection,

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. In addition, the R&C function manages the quality management system (QMS), assists sales activities and coordinates internal & customer audit programs. R&C participates in a range of compliance assessments including HIPAA/HITECH and ISO27001 assessments. R&C 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 compliance professional 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 mitigation activities arising from internal risk management programs.

The successful candidate will be expected to interface with both senior management and the various delivery teams across Oracle Health Sciences to define and maintain our compliance posture in an environment of increasing regulatory expectations and cloud growth.

Key Responsibilities

Responsibilities include:

  • Provide computerised system validation (CSV) and compliance guidance to Oracle Health Sciences product development, services and support functions.

  • Act as a compliance point of contact during regulatory inspections of Oracle customers and any inspections of Oracle under applicable legislation.

  • Contribute to the maintenance of the Oracle Health Sciences Quality Management System (QMS).

  • Assisting Risk & Compliance colleagues during internal / customer / supplier audits.

  • Work with internal teams to implement process/product improvements based on outcome of audit observations.

  • Contribution to the preparation of customer audit or other required responses.

  • Maintaining familiarisation with evolving industry and regulatory requirements particularly in the clinical data management and safety domains. Disseminate information about regulatory developments and educate Oracle Health Sciences accordingly.

  • Represent Oracle Health Sciences on industry bodies and work teams.

  • Provide input and guidance from a regulatory and quality perspective to all Oracle Health Sciences lines of business to facilitate 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 GCP or GPvP environment.

  • Must have a sound knowledge of relevant industry and government regulations (e.g. 21 CFR 11, ICH GCP R2, EU Annex 11, PIC/S, GPvP) in the clinical and/or safety domains, together with demonstrable practical experience of applying these to computerized systems in these domains.

  • Detailed familiarity with computerized systems validation (CSV) approaches (e.g. GAMP5, FDA guidance on software validation), Agile development practices and real world experience applying such approaches to clinical or safety related systems.

  • Candidate must be a self-starter; who takes the initiative, and has the ability to work independently and manage multiple projects/priorities.

  • Must have experience in the development, and maintenance of quality management system.

  • Previous experience of engagement with appropriate industry bodies (e.g. CDISC) and regulators.

  • Superior communication skills (interpersonal,verbal, written).

  • 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.

  • Practical experience with the preparation and conduct of regulatory GXP inspections.

  • Familiarity with Oracle Health Sciences (e.g.Clinical One, InForm, IRT, Argus) products and services desirable.

  • Familiarity with the data privacy requirements in GXP environments.

  • Ability to travel internationally on occasion as required.

Assists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies.

Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Drive the development and implement a comprehensive risk management and regulatory compliance strategy across the GBUs to optimize and continuously improve the information security of the GBU products and services. The role requires coordination between the GBUs' Development, Cloud Services, Services, and Operations teams and Oracle's centralized Corporate Security Group and Oracle Legal organizations. This team will ensure that the IT environment implements, demonstrates and continuously monitors the controls necessary to meet key security frameworks and regulatory specifications including ISO 2700x, PCI DSS,HIPAA and SSAE 16 as needed by the GBUs. Facilitate third party attestations, audits and certification efforts for the GBUs. Develop customer facing documentation that describe the security and compliance across the GBUs including Oracle Cloud for Industry. Assess the Cloud compliance and security landscape to keep OCI controls current with industry standards. Interface with corporate groups including Corporate, Privacy and Security legal and Internal audit to ensure compliance with policy. Lead project team members and formalize risks and key controls associated with significant Oracle Cloud for Industry and GBU processes. Manage the vendor security program for the GBUs. Coordinate audit testing, documentation, self-assessment testing and remediation activities. Make recommendations to correct deficiencies identified during the various audits. Perform the role of compliance consultant and subject matter expert for the Oracle GBUs to help them improve their control environment as necessary. Manage project functions including project scheduling, tracking, communications, and controlling to ensure project meets deadlines and remains on schedule.

Acknowledged authority within the Corporation. Exercises creativity and independent judgment in developing methods, techniques, and evaluation criteria. Ability to travel. 10 plus years experience. Bachelor Degree or equivalent. CISA, CISM, CISSP, CIPP desired. 10+ years related experience. Formal training in project management. Fluency & extensive experience IT auditing and controls, preferable with SOX, SSAE 16 - SOC 1 & SOC 2, PCI compliance, NIST, DIACAP, FedRAMP, ISO 27001 & ISO 27002. Strong working knowledge of IT processes and IT infrastructure. Proven ability to combine business acumen, technical acumen and process expertise to define control specifications for SSAE 16 SOC 1 & SOC 2, PCI, ISO 27002. Demonstrated success in leading, controlling, & completing IT projects. Proven ability to influence & gain buy-in at multiple levels, across divisions, functions and cultures; comfort working with executive level management. Demonstrated ability to achieve results through cross-functional, virtual teams. Ability to prioritize, manage, and deliver on multiple projects simultaneously; highly motivated and able to work against aggressive schedules. Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-pace environment. Superior communication skills (interpersonal, verbal, presentation written, email. Positive attitude, team player, self-starter; takes initiative, ability to work independently. Discretion in handling confidential information.If you are a Colorado resident, Please Contact us or Email us at oracle-salary-inquiries_us@oracle.com to receive compensation and benefits information for this role. Please include this Job ID: 106951 in the subject line of the email.

About Us

Innovation starts with inclusion at Oracle. We are committed to creating a workplace where all kinds of people can be themselves and do their best work. It’s when everyone’s voice is heard and valued, that we are inspired to go beyond what’s been done before. That’s why we need people with diverse backgrounds, beliefs, and abilities to help us create the future, and are proud to be an affirmative-action equal opportunity employer.

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, age, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

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