, or lifesciences industries. Prior experience handling regulatory audits and inspections. Project management experience...
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 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...
+principles. Qualifications: Bachelor's degree in pharmacy, LifeSciences, Chemistry, or a related field. 5+years...
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...
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...
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...
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...
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...
in biotechnology, pharmaceuticals, or lifesciences manufacturing. Roles & Responsibilities: Production Operations: Operate...