- 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
- 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
- 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
- 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 (Manchester, NH)
- …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
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