Intern, Regulatory CMC, Digital and Knowledge Management

  • 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. Within Regulatory CMC, the Regulatory Intelligence, Policy, and Knowledge Management team, and the Strategic Operations and Business excellence teams are focused on driving continuous improvement and transformative ways of working across all products.

Position Description

Successful application of Digital and Knowledge Management (KM) capabilities requires shifts in mindsets and rely heavily on people to drive meaningful change to optimize and transform our ways of working. These concepts are fairly nascent within the organization and require strong communications and learning to effectively brand them and the value they could bring to the organization.

Weeks 1-2: The knowledge acquisition phase will include regular meetings with the digital & KM leads, and the digital realization office with a goal after two weeks of clear understanding of the problem being solved and expectations for the deliverables.

Weeks 3-5: The information processing phase will focus on gathering existing collateral (e.g., training materials, tools, reports etc.), and brainstorming a framework for effective communication and training across digital and KM within Regulatory CMC.

Weeks 6-10: The strategy development phase will focus on developing a communication strategy and a learning strategy across KM and digital. This strategy will help drive adoption of relevant tools, increase our digital and KM fluency, and establish quantitative & qualitative methods for measuring progress in such areas.

Weeks 11-12: The close-out will focus on rolling out the communication and learning plans to the department, capturing the process for future maintenance of these plans, and developing a formal read-out for the project (PowerPoint).

Qualifications

Experience in communication, branding, and marketing strategies, and developing training materials.

Include the knowledge, skills, and abilities you may be seeking:

  • General understanding of the pharmaceutical industry and regulatory functions
  • Must have experience with developing communication strategies • Must have experience with developing E-Learnings
  • 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

Business, Marketing or relevant degree.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Privacy Policy