Job Description: The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individu...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Job Summary : The Senior CSV Engineer – Project Lead is responsible for leading and executing Computer System Validation (CSV) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (EBR) platforms. This role ...
Responsibilities: This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects, ensuring compliance with FDA and EU regulation...
Roles & Responsibilities: Develop a deep understanding of global Rapid Diagnostics distribution processes, systems, and business programs to identify operational risks, inefficiencies, and opportunities for improvement. Lead the creation...
Roles & Responsibilities: Ensure compliance with GMP, GLP, and GDP requirements across manufacturing and quality operations. Review and approve SOPs, protocols, batch records, and other controlled quality documents. Lead and support dev...
Job Summary: Medical Device Quality Engineer responsible for supporting the launch of a new medical device product into production at an onsite manufacturing facility in Devens, MA. The role focuses on process validation, risk managemen...
Job Description: The Manufacturing Associate I is responsible for supporting the production of therapeutic proteins (Active Pharmaceutical Ingredients - API) under strict cGMP conditions. This entry-level role involves executing manufactur...
Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content, review of edit check...
Roles & Responsibilities : Monitor due dates for lab instrument reviews and coordinate with stakeholders. Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+data integrity. Perform gap analyses, remedi...