- 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
- Parexel (Boston, MA)
- …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
- Parexel (Boston, MA)
- **Job Summary:** The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate (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
- 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
- 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
- FM (Waltham, MA)
- …leverage their experience within investment operations, including counterparty management, regulatory compliance and risk management exposure, strong technical ... managed accounts. Investment Operations is seeking a highly motivated and detail-oriented ** Senior Investment Operations Analyst** to play a lead role in supporting… more
- Applied Research Solutions (Bedford, MA)
- …package, our awards and recognition program, and personalized attention from ARS Senior Managers. **Responsibilities include:** Duties include, but not limited to: + ... and develop various brie?ngs/schedules of program status and acquisition tasks to senior management + Provide expert Program Management inputs to Request for… more
- Santander US (Boston, MA)
- AVP, Regulatory Relations Senior Associate - Treasury Country: United States of America **Your Journey Starts Here:** Santander is a global leader and innovator ... to Talk to You!** **The Difference You Make:** The Senior Treasury Regulatory Relations Associate is the...capital, interest rate risk, balance sheet management) to translate technical content into regulatory -ready materials. + Monitor… 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)
- …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
