- Merck (Cambridge, MA)
- …understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions . + Work closely with pharmacometrics team ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Commonwealth Care Alliance (Boston, MA)
- …and for a full program audit. + Participate in data quality checks for regulatory reporting submissions by verifying data in Guiding Care and identifying missing ... attachments, etc + Communicate and work collaboratively with AG Representatives, Resolution Specialist and Management to maintain and improve quality of operations. + Act as a CCA content expert on State and Federal Grievance and Appeal regulations for all CCA… more
- Needham Bank (Wellesley, MA)
- …possible cases of fraud and/or Money Laundering. + Ensure that deadlines for regulatory related report submissions are met and that that customer monitoring ... understanding BSA/Compliance and Fraud regulations and requirements. + Assist management in regulatory exams. + Uphold the strict BSA related standards set forth by… more
- IQVIA (Boston, MA)
- …mentoring and developing others in the use of CDISC standards + Experience in submissions to regulatory authority preferred IQVIA is a leading global provider of ... study specifications that align to the CDISC standards and regulatory agency guidance's. This position provides this guidance and...requirements as defined by FDA Guidance Documents and other regulatory guidance. + Guide clients in their use of… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …of study records, and resolution of data queries. + Prepare and or complete regulatory related reports and IRB submissions . Maintain and organize study ... protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of study records, and resolution of data queries. + Prepare and or complete regulatory related reports and IRB submissions . Maintain and organize study ... protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all state, federal, and… more
- Teleflex (Chelmsford, MA)
- …the NC and CAPA systems as needed to structure activities. * Support Regulatory Affairs with relevant submissions , approvals, requests, and inquiries. * Partner ... risk management activities for supported products * Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of study records, and resolution of data queries. + Prepare and or complete regulatory related reports and IRB submissions . Maintain and organize study ... ensuring the timely collection and shipment of protocol-required samples, maintaining regulatory binders, and ensuring compliance with all institutional, state, and… more
- US Tech Solutions (Cambridge, MA)
- …difficulties + Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents ... + Participates in department-wide support efforts such as safety, recruiting and committees + May train staff and/or supervise others + Coordinates and organizes resources needed to complete the task + Understands when to seek input and when to make… more
- Canon USA & Affiliates (Boston, MA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. **RESPONSIBILITIES** + Remote position, **west… more
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