- Repligen (Waltham, MA)
- …Audit, and external auditors.Communicate risks, findings, and recommendations to both technical and non- technical stakeholders, including senior ... strengthen Repligen's control environment.ResponsibilitiesKey ResponsibilitiesLead the planning, execution, and documentation of SOX IT testing activities, partnering closely with… 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject ... matter expertise, technical guidance, and leadership for the application of health...for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304,… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate I (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... reports required information to resolution + Submit all required reports, documentation , updates and tracking within required timeframes, including but not limited… more
- United Site Services (Westborough, MA)
- …and excellence in every aspect of our business. **Primary Purpose** The Senior Director of Enterprise Applications is a hands-on leader responsible for driving ... design and optimize business processes. + Translate business requirements into technical designs and system configurations. + Oversee testing and validation efforts,… more
- Integra LifeSciences (Braintree, MA)
- …to advance patient outcomes and set new standards of care. **SUMMARY** The ** Senior Facilities Technician - HVAC & Refrigeration** is responsible for a wide range ... environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA, ISO). + Maintain accurate records of refrigerant… more
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- 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
