Neurodiverse Intern, Human Factors Regulatory

Company Description

This internship role is part of the Limitless @ Biogen program; the summer co-op for neurodiverse college students. ‘Neurodiversity’ includes neurological differences such as autism spectrum, ADHD and dyslexia. Applicants will not be asked for documentation or proof of neurodiversity, unless requesting an ADA accommodation. Limitless @ Biogen provides support for managers and interns throughout the 6-month co-op. 

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.   

As an intern or co-op at Biogen, you can expect to be placed on a real project, under the guidance of experience 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 2024. Resume review begins in February 2024. 

Biogen delivers novel therapeutics to our patients, often through the use of device delivery systems. Pairing a drug with a device is called a combination product. Biogen cross-functional teams develop combination products to treat patients across a range of therapeutic areas, including neuroscience, immunology, multiple sclerosis and rare diseases.  As an intern in the Device team, you will explore device design, understand how a device can impact a patient’s experience and better appreciate how regulatory authorities ensure that products are safe and effective. During this internship, you will have the opportunity to: 

• Engage in human factor activities to support the development of combination products and ensure the device and instructions for use are designed for safe and effective use by the intended user in their intended use environment. 
• Develop processes and templates for use in regulatory submissions.  
• Analyze and compile submission data for combination products pulled from publicly available regulatory databases. 

Position Description 

As an intern, you will have opportunities to assist and conduct human factors studies with combination products during the summer timeframe. They will also have opportunities to work outside of the device team, i.e., Packaging Development, Continuous Improvement, and Facilities. 

• Author human factors engineering deliverables on drug delivery devices such as usability plan, task analysis, usability study protocol, and report based on regulatory guidance and principles. 
• Work within the cross-functional team (Quality, Risk Management, Regulatory, Packaging, Human Factors, etc.) to support design control activities for drug delivery devices 
• Analyze study result data using statistical techniques and software   

There are many types of regulatory submissions. One of particular interest to the Human Factors team is submitting protocols to the Division of Medication Error Prevention and Analysis (DMEPA). Regulatory team members work hand-in-hand with the technical subject matter experts to ensure submissions include required content. The intern will be responsible for documenting a standardized approach and template(s) to ensure consistency in approach and format.   

Information about approved drugs and combination products is publicly available through regulatory databases. This regulatory intelligence can provide insights into current opinions and interpretations of regulators and help set strategy during development of new products. The intern will be responsible for reviewing, assessing and compiling information pulled from Summary Basis of Approval (SBAs) and CHMP Opinions for combination products to gather insights into recent regulatory submissions. Through this analysis, they will be able to identify risks and opportunities, and share findings to cross-functional device teams.  

Qualifications

• Ability to work independently and also collaborate with the cross-functional team and external vendors 
• Strong communication skills (written, verbal, presentation) 
• Strong work ethic, time management, and leadership skills  

Optional 

• Prior intern / co-op experience is a plus 
• Understanding of Human Factors FDA guidance, ANSI/AAMI HE75, ISO/IEC 62366 
• Previous experience in the medical device industry is a plus 

To participate in the Biogen Internship Program, students must meet