Key Responsibilities

• Develop, enhance, and support Oracle Fusion Cloud technical solutions based on business and functional requirements.
• Design, develop, and maintain BI Publisher reports, data models, templates, bursting solutions, and scheduled processes.
• Develop and support OTBI analyses, dashboards, and self-service reporting solutions.
• Design, develop, and maintain Fusion Data Intelligence dashboards, datasets, and analytics solutions.
• Develop and support integrations using Oracle Integration Cloud, REST APIs, SOAP web services, file-based integrations, and middleware technologies.
• Build and maintain automated data loads and interfaces utilizing FBDI, HDL, BICC, and other Oracle integration frameworks.
• Analyze Oracle Fusion data structures and leverage SQL and reporting tools to support business reporting and troubleshooting requirements.
• Configure and support Oracle Fusion extensions and customizations, including Visual Builder Studio, Redwood UI components, and Application Composer.
• Support Oracle Fusion security, roles, privileges, and data access controls.
• Troubleshoot and resolve production issues involving reports, integrations, interfaces, scheduled jobs, and data processing.
• Participate in technical design, development, code reviews, testing, deployment, and release activities.
• Prepare and maintain Technical Design Documents, interface specifications, support documentation, and knowledge articles.
• Collaborate with functional teams to translate business requirements into efficient and scalable technical solutions.
• Adhere to enterprise standards for development, security, documentation, and change management.
• Support adoption of emerging Oracle technologies, including Oracle AI Agent Studio and AI-powered capabilities within Oracle Fusion Cloud.

Required Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, or a related discipline.
• 5+ years of Oracle ERP technical experience, including hands-on experience with Oracle Fusion Cloud ERP.
• Strong experience developing and supporting Oracle Fusion ERP, BI Publisher, OTBI, Fusion Data Intelligence, Oracle Integration Cloud, REST and SOAP APIs, FBDI, HDL, and BICC.
• Strong understanding of Oracle Fusion data structures, reporting architecture, and integration frameworks.
• Experience with integration monitoring, error handling, reconciliation, and production support.
• Familiarity with Git-based source control and deployment practices.
• Working knowledge of Oracle Fusion security concepts, role-based access controls, and governance practices.

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The successful candidate will have 6-9 years of Regulatory Affairs experience, preferably in biologics, with strong expertise in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities.

Key responsibilities include:

• Contributing to project teams and projects on a day-to-day basis
• Acting as a representative of the GRAS regulatory department with other departments
• Providing technical expertise to proposals and assisting with Business Development initiatives
• Understanding project budgets, scope of projects, allocated hours, and tracking compliance
• Interacting with internal and external personnel, clients, and technical experts on projects
• Conducting regulatory research on projects as needed
• Preparing consulting reports under guidance
• Arranging, leading, and reporting on client meetings
• Contributing to regulatory agency meetings
• Writing IND and product registration dossiers, clinical reports, and other regulatory documents for submissions
• Preparing full regulatory submissions for INDs, product registrations, and post-approval maintenance activities
• Acting as a resource for technical knowledge
• Participating in quality improvement efforts to increase overall operational efficiency
• Contributing to the building of the regulatory systems and infrastructure needed for GRAS
• Developing a reputation for the Company as an industry leader in Regulatory
• Providing internal training in appropriate areas of expertise to other Departments

The ideal candidate will have:

• A BS degree, preferably in a science-related field or equivalent experience
• Moderate regulatory, pharmaceutical/medical device related experience
• Demonstrated experience in contributing to the preparation of regulatory submissions
• Excellent interpersonal and communication skills
• Excellent customer service skills
• Good quality management skills
• Problem-solving and decision-making skills
• Advanced skills in Microsoft Office Applications
• Ability to interact with staff from multiple departments and offices
• Good initiative, adaptability, and pro-activity
• Strong analytical skills and attention to detail
• Ability to work concurrently on projects
• Fluent in speaking, writing, and reading English

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The successful candidate will be responsible for various safety and pharmacovigilance activities, including:

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs
• Assist in processing ICSRs according to SOPs and project-specific safety plans
• Triage ICSRs, evaluate data for completeness, accuracy, and regulatory reportability
• Enter data into safety database, code events, medical history, concomitant medications, and tests
• Compile narrative summaries, identify information to be queried, and follow up until queries are resolved
• Assist in generating timely and accurate reporting of expedited reports
• Maintain safety tracking for assigned activities
• Perform literature screening and review for safety, drug coding, and MedDRA coding
• Validate and submit xEVMPD product records
• Identify and manage duplicate ICSRs
• Participate in audits as required

The ideal candidate will have:

• A Bachelor's degree in life sciences, nursing, pharmacy, or equivalent
• Approximately 2 years of experience in Safety & Pharmacovigilance
• Russian language skills are a must-have
• Knowledge of safety database systems and medical terminology
• Understanding of clinical trial processes and post-marketing safety requirements
• Proficiency in Microsoft Office Suite and other software applications
• Excellent communication and interpersonal skills

Syneos Health offers a dynamic work environment with opportunities for career growth and development.

The salary for this position is not specified.

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