- Parexel (Albany, NY)
- …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
- Oracle (Albany, NY)
- …AI-enabled population health platform. To support these efforts, we are hiring ** Regulatory Technical Documentation Engineers** with **deep engineering ... documentation + Experience preparing documentation for audits, technical files, or regulatory submissions. **Preferred** + Experience in healthcare,… more
- Oracle (Albany, NY)
- **Job Description** Oracle Health Data Intelligence (HDI) is hiring a Principal Technical Program Manager - Operations to lead key strategic and operational ... leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both… more
- Oracle (Albany, NY)
- …development lifecycle, enabling teams to maintain compliance through automated traceability and documentation . + Support audits, technical documentation , and ... **Job Description** As a Principal Member of Technical Staff, you...and relevant FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation , and… more
- Oracle (Albany, NY)
- …focus on excellence. **The Role** We are looking for an experienced Technical Program Manager who is proactive, results-oriented, and demonstrates strong ownership ... Program Management and Engineering to improve SLAs and mitigate risk, ensure regulatory compliance, and advance operational integrity. Serve as a trusted partner for… more
- Fujifilm (Albany, NY)
- …written documentation , periodic review, and Intranet postings + Excellent written technical documentation skills and ability to generate concise and accurate ... **Position Overview** The Principal Enterprise Architect is the technical ...business continuity and disaster recovery implementation + Expert level technical documentation skills + Certifications are a… more
- Oracle (Albany, NY)
- …stakeholders, manage high-stakes vendor relationships, and navigate the complexities of regulatory compliance. Your ability to anticipate and mitigate risks to ... with internal teams to make sure we deliver the proper design and process documentation to the Colo, execute on our ISP circuit contracts, and update all internal… more
- Oracle (Albany, NY)
- …years of experience in AI/ML solution development, with 5+ years in senior or principal technical roles. + Proven track record leading large-scale, production AI ... discussions, helping shape the future of responsible healthcare AI. + Publish technical insights, speak at conferences, and mentor Principal -level engineers and… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Regeneron is currently looking for a Principal External Manufacturing (EM) Specialist to join the Advanced Therapies External Manufacturing Team that specializes in ... Supply (IOPS) product supply chains. The role of the Principal Specialist External Manufacturing is to act as the...cycle times and providing any required associated reports and technical expertise. + Functioning as a liaison between Regeneron… more
- GE Vernova (Schenectady, NY)
- … excellence and knowledge sharing. + Prepare and present detailed technical documentation , system specifications, and progress reports to stakeholders. ... and certification of components. + Have ability to define comprehensive technical requirements, specifications, and controls interface documentation for power… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Regeneron is currently looking for a Principal External Manufacturing (EM) Specialist to join the Advanced Therapies External Manufacturing Team that specializes in ... partners including day-to-day operations, ensuring timely completion of associated operations/ documentation , and assisting in the monitoring of cGMP compliance. As… more
- Oracle (Albany, NY)
- …surveillance processes are embedded into SDLC activities. + Translate regulatory requirements into clear engineering controls, documentation workflows, ... engineering programs in regulated environments. + Demonstrated ability to translate regulatory requirements into technical workflows, SDLC practices, and… more
- Oracle (Albany, NY)
- …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
- Oracle (Albany, NY)
- …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
- Oracle (Albany, NY)
- …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
- Oracle (Albany, NY)
- …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
- Oracle (Albany, NY)
- …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
- Oracle (Albany, NY)
- …where you'll belong and be encouraged. **Who are we looking for?** In this Principal Technical Program Management role, you will be working across a ... and ability to summarize complex trade-offs and options in presentation and technical documentation . + Ability to effectively represent engineering perspectives… more
- Regeneron Pharmaceuticals (Menands, NY)
- …control systems and product release testing systems. + Are familiar with regulatory and quality policies, procedures, documentation methods. + Enjoy working ... system configuration, including requirement and/or design specifications, test plans, technical evaluation, and quality risk assessments. + Providing end-user… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …and repairs + Have experience writing and executing test plans and technical evaluations to demonstrate equipment suitability for change control documentation ... working in a cross-functional team environment + Strive for compliance with regulatory , corporate, and site-specific policies and procedures + Are open and receptive… more
