- Oracle (Juneau, AK)
- …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
- Otsuka America Pharmaceutical Inc. (Juneau, AK)
- …post-approval supplements). Determine regulatory CMC content and scientific/ technical requirements to ensure documentation meets regulatory ... Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process...Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop… more
- Oracle (Juneau, AK)
- …leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both ... and compliance activities** as HDI expands globally. Ensure operational processes and documentation align with regulatory standards and help drive readiness for… more
- Oracle (Juneau, AK)
- …and ability to summarize complex trade-offs and options in presentation and technical documentation . + Ability to effectively represent engineering perspectives ... and working on ambitious new initiatives. A TPM at any level can have significant technical and business impact here. You will be part of a team of hard-working,… more
- GRAIL (Juneau, AK)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
- Oracle (Juneau, AK)
- …of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends ... 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… more
- Oracle (Juneau, AK)
- …Key Responsibilities 1. Strategic Technical Leadership + Serve as the senior technical authority on designing and delivering AI/ML-powered health data ... scale. + Influence product roadmaps by representing real-world customer requirements, regulatory constraints, and innovation opportunities to senior product and… more
- Parexel (Juneau, AK)
- …regulations. + Broad experience in preparation of all types of clinical regulatory documentation . Experience in management of complex medical writing projects. ... The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales… more
- Coinbase (Juneau, AK)
- …of compliance speak and into functional requirements and across varying levels of technical stakeholders. * Regulatory familiarity: Working knowledge of major ... supported. Coinbase is looking for a creative and analytical Senior Analyst of Technology Risk. You will serve as...and will make these applicable and usable for fast-moving technical teams located across global time zones. *What you'll… more
- GCI Communication Corp (Anchorage, AK)
- …(POCs) for new cloud networking technologies and methodologies. + Develop technical documentation , network diagrams, and architecture blueprints. + Automate ... GCI's Senior Cloud Platform Solutions Architect will overall be...be responsible for guiding and setting infrastructure service lines' technical direction and architecture in all aspects of the… more