Intern, Regulatory CMC, Knowledge Capture/Transfer
- Full-time
- Region: US
- Department: Regulatory
Company Description
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.
Job Description
This application is for a 12-week internship role from June - August 2023. Resume review begins in January 2023.
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.
Position Description
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.
Qualifications
- Must have experience in MS Power Apps, Power Automate, SharePoint, and general Microsoft Office suite of products (Excel, Word, PowerPoint)
- Technical expertise with user interface development and automations
- Strong verbal and written communication skills
- Strong accountability and project management skills
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 college or university
Education
Computer Science, Programming, or relevant degree.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.