Intern: R&D Audit

Biogen SANDBOX • Cambridge, MA

6d

About The Position

As an integral part of the R&D Quality Management System, Biogen R&D Audit plans and executes audits in support of the R&D Quality Principles including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP) and Good Pharmacovigilance Practice (GVP) audits. This role will perform activities to ensure access to data and information for decision-making and trending. It will reduce the risk of R&D Audit and Audit Stakeholders using outdated or redundant information and will improve efficiency and standardization. This role will learn about Good Documentation Practices (GDP), Quality Management Systems, GxP Audit, Document and Record Management and Retention and Quality technologies. The R&D Audit Specialist will perform document and record management activities. As an integral part of the R&D Quality Management System, Biogen R&D Audit plans and executes audits in support of the R&D Quality Principles including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP) and Good Pharmacovigilance Practice (GVP) audits.

Requirements

• Legal authorization to work in the U.S.
• Enrollment in a full-time undergraduate or graduate program, returning to the academic program fol

Responsibilities

• Ensuring all R&D Audit paperwork is scanned, stored, labeled and indexed in a logical, transparent, and easily retrievable manner
• Ensuring all R&D Audit electronic files are stored, labeled and indexed in a logical, transparent, and easily retrievable manner
• Reconcile documents and data and create an inventory

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees