Intern, Regulatory CMC, Knowledge Capture/Transfer

At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Together, our employees create, commercialize, and manufacture transformative therapies for our patient population.

We at Biogen are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients who we serve. We are focused on strengthening our foundation to advance our overall Diversity, Equity and Inclusion (DE&I) strategy and, most importantly, ensure all our employees feel included.

As an intern or co-op at Biogen, you can expect to be placed on a real project, under the guidance of experienced professionals and subject matter experts who are invested in your career and academic growth. We also ensure that you have plenty of opportunities to build your network, learn more about our organization through weekly lunch and learns led by leaders from across the company, and join us for several fun events.

Regulatory CMC supports our Pharmaceutical Operations and Technology organization by influencing, enabling, and sustaining regulatory approvals of innovative therapies to serve patients. We present Chemistry, Manufacturing, and Control (CMC) documentation to global regulators and manage subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned. The Regulatory Intelligence, Policy, and Knowledge Management team serves as a key function which works towards integrating our regulatory knowledge and intelligence directly into the flow of work for Regulatory CMC. The Strategic Operations and Business excellence teams are focused on driving continuous improvement and transformative ways of working across all products.

Simplifying and automating Knowledge Capture and Knowledge Transfer: Capturing and transferring knowledge are currently manual processes done on Word/PowerPoint. This creates a high activation energy and obstacle towards fulfilling these necessary functions within the department. As an intern with technical design background, you will work on creating a more automated and integrated user interface, thereby lowering this activation energy and increasing departmental compliance.

Weeks 1-2 will include frequent meetings with KM Lead to share background on Knowledge Capture/Transfer within Regulatory CMC, with the goal after 2 weeks of clear understanding of the problem being solved. This is the information gathering phase.

Weeks 3-4 will include the proposal and mock-up phase, where the intern will create a vision and proposal for the user interface of the Knowledge Capture/Transfer tool. Check-ins with KM Lead will help to align progress with vision and ensure alignment.

Weeks 5-10 will involve the technical work, creating the working interface itself, equipped with automation and integrated user interface. Continued alignment with KM Lead will be necessary. Additional alignment with Digital Lead will be helpful in this phase as well. Considerations for beta-testers during this period will help continue adoption and direction.

Weeks 11-12 will involve a detailed summary of the project in PowerPoint/Word, as well as any documentation on “How-to-use”. This is the close-out phase. A successful close-out will mean that the Regulatory CMC department knows what steps the intern took to deliver the tool, and that the KM & Digital Leads know how the tool functions for future maintenance and updates.

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

Computer Science, Programming, or relevant degree.

Remote