Co-op, Annual Product Review Project Specialist
: Job Details :

Job Description

This application is for a 6-month student role from January - June 2025. Resume review begins in October 2024.

The Annual Product Review (APR) is a GMP (Good Manufacturing Process) requirement for all countries where Biogen's products are marketed. This project corresponds with Biogen's mission to discover, develop and deliver worldwide Innovative therapies for people living with serious diseases. The APR is a regulatory requirement and reviewed in almost every agency inspection. This position will be reporting into the Knowledge Management organization under Product Development Quality. Our organization is responsible for Global Quality oversight of Biogen's products throughout the Product Development Lifecycle.

This position will provide an in depth understanding of what is required to comply with global APR regulations and how Biogen assures compliance with these requirements.

Position Description

This position will be responsible for facilitating implementation of APR process improvements to drive increased compliance and to reduce the workload required to prepare the APR.

Detailed description of role including but not limited to:

• Tracking and following up with section report authors to track the status of APR section reports to assure they will be completed on time.
• Interviewing APR Section report authors to gather data on how much time is being spent preparing these reports.
• Attending meetings with section APR report authors to review APR templates and work instructions to identify/implement improvements.
• Tracking and communicating the status of section report templates and work instruction improvement.
• Preparing meeting minutes to assure all involved parties understand what decisions were made and action items.

Example projects may include:

• Implementation of APR templates and work instructions across all modalities (Biologics, Small Molecules, Antisence Oligonucleotides).
• Development of an effective “Touch Time” report to calculate APR report workload and workload reduction with implementation of the new templates.
• Effective tracking tool for understanding and communicating the status of APR reports across the PDQ organization.

Qualifications

• Proficient in MS Teams, Sharepoint, Excel
• Possess excellent communication and collaboration skills
• Basic understanding of GMP in a Biotech/Pharmaceutical environment.

To participate in the Biogen Internship Program, students must meet the following eligibility criteria:

• Legal authorization to work in the U.S.
• At least 18 years of age prior to the scheduled start date
• Be currently enrolled in an accredited community college, college or university

Education

• Bachelor or Master's degree in communication, business administration or the Biological or Chemical sciences.

Location

This role is on-site in Research Triangle Park, NC.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.