Intern: R&D Audit

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 It will reduce the risk of R&D Audit and Audit Stakeholders using outdated or redundant information and will improve efficiency and standardization.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. Activities include but are not limited to:

• 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

To participate in the Biogen Intern or Co-op Program, students must meet the following eligibility criteria:

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

This is a full-time internship role from June – August 2019 located in Cambridge, MA.

Deadline for applications is March 15, 2019.

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.