- 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
- 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
- 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
- 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
- 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)
- …coordination, EMA linguistic reviews, and US SPL submissions. + Maintain labeling documentation within eDMS and regulatory tracking platforms; ensure robust ... ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets? Parexel… 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)
- …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
- 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
- Parexel (Boston, MA)
- …and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a ... **Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience...+ Background in medical writing or strong familiarity with regulatory documentation processes. + Hands-on experience in… 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
- PPL Corporation (Providence, RI)
- …responsible for reporting and financial activities which require knowledge of technical accounting procedures, rules, and regulations, particularly as they relate to ... quarterly and annual financial reports and filings with the Federal Energy Regulatory Commission (FERC), state regulatory bodies, and others, including FERC… 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
- PPL Corporation (Providence, RI)
- …and enhancing internal controls over financial reporting. This is a senior -skill level normally without supervisory responsibility. However, may provide guidance and ... to all the above processes, expected to develop supporting work papers and documentation . + Builds knowledge of the organization processes and customers and … more
