- Oracle (Indianapolis, IN)
- …with regulatory and organizational requirements. + Write and maintain technical documentation , including software design and standard operating procedures. + ... **Job Description** Join our innovative automation team as a Principal Software Developer, focused on designing, developing, and maintaining software-driven… more
- Lilly (Lebanon, IN)
- …The Scientist - Quality Control Project Management - Advanced Therapies is a technical role in the Quality Control Laboratory helping to ensure the manufacture of ... successful candidate will work in partnership with internal LP2 personnel for technical support, with the Lilly global Analytical Sciences and Quality Control… more
- Oracle (Indianapolis, IN)
- …across multiple functions within Oracle, ensures compliance with strict regulatory standards, and provides design leadership from concept through execution. ... ensuring milestone achievement, quality, compliance, and adherence to company and regulatory standards. + Conduct site assessments, participate in design meetings,… more
- Lilly (Indianapolis, IN)
- …+ Experience in quality support for Quality Control activities + Thorough technical understanding of quality systems and regulatory requirements. + Knowledge ... in accordance with the validated process and are compliant to cGMPs and regulatory commitments. The Associate will need to interact daily with a wide variety… more
- Oracle (Indianapolis, IN)
- …through data and technology. Career Level - IC4 **Responsibilities** **Responsibilities** 1. ** Technical Leadership** : * Serve as a key technical expert ... Develop and fine-tune LLMs for healthcare-specific use cases, such as automated documentation , question answering, and predictive analytics. * Apply generative AI to… more
- Parexel (Indianapolis, IN)
- …to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator ... model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports,… more
- Lilly (Indianapolis, IN)
- …You will work in our Cloud Engineering area working on the global technical operations of cloud computing capabilities for Lilly. Additionally, you would be working ... + **Security & Compliance:** Deep understanding of cloud security principles, regulatory standards (eg, HIPAA), and best practices for securing cloud infrastructure… more
- Oracle (Indianapolis, IN)
- …of ** regulatory compliance processes** (FDA, ISO, cGMP) and quality documentation management. + Familiarity with **Oracle Visual Builder Studio** , **BI ... modules, ensuring alignment with compliance standards. + Partner with **Integration and Technical teams** to design robust data flows between PLM and ERP systems… more
- Wolters Kluwer (Indianapolis, IN)
- …+ Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix, protocols, reports, risk ... The ** Principal SaMD Technical Program Manager** plays...for tracking and communicating key metrics-such as risk information, documentation completeness, and team velocity-to both technical … more
- Oracle (Indianapolis, IN)
- …and continual improvement. _Stakeholder Training & Enablement_ + Design and deliver technical training, guidelines, and documentation for: + Third-party security ... CCPA) and industry standards for wireless monitoring. + Ability to balance technical , business, and regulatory considerations. + Experience with Agile… more
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