- Oracle (Boston, MA)
- …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
- Parexel (Boston, MA)
- …labeling expertise into strategic impact? We're seeking a sharp, detail-driven ** Senior /Consultant, Regulatory Labeling** to join a dedicated partnership with ... go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations, Safety, and Commercial. You'll help… more
- Eversource Energy (Westwood, MA)
- …immigration documents, or any work authorization that requires company involvement or documentation \(e\.g\., H\-1B, OPT, STEM OPT, CPT, TN, J\-1, O\-1, etc\.\)\. ... training, or other business needs\) or should the policy change_ This Senior Analyst role is responsible for the benefit\-cost analysis \(BCA\), regulatory… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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 (Boston, MA)
- …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 (Boston, MA)
- …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
- Fujifilm (Boston, MA)
- **Position Overview** The Senior Technical Support Engineer, MI - I (Tier 1) provides highly visible remote technical support across our product lines for ... with peers and other team members when working on more complex technical issues. + Effectively documents cases throughout the process of troubleshooting the… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …VT, MA, RI, CT)** Reporting to the Director of Billing Compliance, the Senior Billing Compliance Reviewer ensures the integrity, accuracy, and regulatory ... role conducts complex, risk-based audits across coding, charge capture, and documentation to assess adherence to government, payer, and institutional billing… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... alignment of the labeling strategy and labeling content. **Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with TAU/MPD Labeling… more
- Sanofi Group (Cambridge, MA)
- …with regulatory bodies interaction + Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, ... **Job Title:** Senior Clinical Research Director **Location:** Cambridge, MA or...and investigators + Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission… more
- GRAIL (Boston, MA)
- …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
- Sanofi Group (Cambridge, MA)
- …with regulatory agency interactions + Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge,...and investigators + Responsible for the clinical part of regulatory documents, Common Technical Document for submission… more
- Chiesi (Boston, MA)
- …and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements. ... on regulatory guidance documents that impact US activities related to Regulatory activities. + Interact with senior management, external departments and … more
- Oracle (Boston, MA)
- …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
- Capital One (Boston, MA)
- …teams to ensure our security responses are accurate and reflect our latest technical and regulatory standing. + RFI/RFP Response: Analyze and respond to ... + At least 4 years in customer-facingroles, acting as a trusted advisor to senior security and IT leaders. + Deep technical understanding of cybersecurity… more
- Coinbase (Boston, MA)
- …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
- Oracle (Boston, MA)
- …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
- Hologic (Marlborough, MA)
- …through technical leadership, root cause analysis, and adherence to regulatory standards. You'll drive process and product improvements by analyzing post-market ... and execute protocols for verification/validation activities. + Maintain accurate records and documentation per FDA and other regulatory requirements. + Interact… more
- North Shore Community Health (Salem, MA)
- Senior HR Operations & Systems Manager Salem, MA (http://maps.google.com/maps?q=27+Congress+Street+Salem+MA+USA+01970) Job Type Full-time Description The Senior ... compliant HR operations. In addition to leading HR analytics, compliance documentation , audits, and process optimization, this role also manages the Talent… more
- Oracle (Boston, MA)
- …and audit readiness. + Prepare and maintain detailed incident records, technical documentation , post-mortem analyses, and operational runbooks. + Collaborate ... **Job Description** ** Senior Network Development Engineer** **MUST BE A US...audits as required. + Maintain, organize, and update detailed technical documentation , including network diagrams, incident records,… more