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IT Business Systems Analyst

Saxon Global  –  Boston, MA, 02298
... Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC Experience working in a GxP environment(s) (FDA, EU, MHRA) is required. Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6. Bachelor's degree in ... - Jun 09

Senior Manager, Regulatory Affairs

Editas Medicine  –  Cambridge, MA
... Regulatory Agency Interactions: Support the regulatory lead in preparing for Health Authority meetings with agencies, including the FDA, EMA, and other global regulatory authorities, representing the company in regulatory interactions, meetings, and ... - Jun 02

Patient Education Manager - Northeast

Ionis  –  Boston, MA
160000-230000 per year
... the FCS community educating patients, and HCP's such as physicians, nurses, billing managers, and office staff regarding the approved clinical information in relation to the FCS disease state and the appropriate use of Olezarsen once FDA approved. ... - Jun 05

Regulatory Affairs Director

SpringWorks Therapeutics  –  Boston, MA
... Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of ... - Jun 08

Health Systems Specialist

Taylor Strategy Partners  –  Boston, MA, 02298
... They had a recent FDA approval and have a robust pipeline in the Dermatology space. If you love having scientific dialogue and want an environment that uses your unique skills and abilities in a fast-paced, small-pharma environment, we're the team ... - Jun 10

Lead Software Engineer

Curate Partners  –  Boston, MA, 02298
... HIPAA, CLIA, FDA, SOX). · Working knowledge of Agile Frameworks (Scaled Agile) and tools (Atlassian Jira). · Web application and microservice development background · Azure Data Factory background · Python background · Salesforce background · Azure ... - May 19

VP, Regulatory Affairs & Quality

Vigil Neuroscience, Inc.  –  Watertown, MA, 02472
... The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality ... - Jun 04

Production Maintenance Mechanic

North Coast Seafoods  –  Boston, MA
... fine manipulation, pushing and pulling · Work requires the following motions: bending, twisting, squatting and reaching · Exposure to FDA approved cleaning chemicals · Exposure to temperatures: <32 degrees Fahrenheit · Ability to work in wet and dry ... - May 21

Plant Manager - Commercial Bakery

Tribute Baking Company  –  Dorchester, MA, 02122
... Maintains compliance with FDA, OSHA, State agency and markets regulations. Effectively manages payroll and expense budgets. Participates in the budget development. Works with all departments to coordinate all activities within the company that arise ... - Jun 01

Associate Director/Director, Regulatory Affairs, Advertising

Alkermes  –  Waltham, MA
... Communicates with FDA and contributes to health authority negotiations as necessary. This is a hybrid position, onsite at our Waltham, MA office. Key Responsibilities: Provide oversight and review of product and disease state education materials for ... - Jun 03
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