Responsibilities: Value Stream Assessment & Process Design: End-to-end value stream definition, assessment and mapping. Value stream diagnostic including process improvement opportunities, pain-point identification, process waste etc. E...
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...
, or lifesciences industries. Prior experience handling regulatory audits and inspections. Project management experience...
working environment Bachelor's degree in a relevant field, such as lifesciences, regulatory affairs, or a related discipline...
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...
in biotechnology, pharmaceuticals, or lifesciences manufacturing. Roles & Responsibilities: Production Operations: Operate...
+principles. Qualifications: Bachelor's degree in pharmacy, LifeSciences, Chemistry, or a related field. 5+years...
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...