Intern, Regulatory Science - Biologics Mylan 652 reviews - Canonsburg, PA 15317 Full-time, Internship Primary Location * USA-PA-Canonsburg Organization * Mylan Inc. Intern, Regulatory Science - Biologics - 18001035 For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you. Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help: * Support updating and maintaining data base for all IRs/observations received during review of BLAs from health authorities. * Provide analysis on trends, FAQs to better inform new submissions. * Enter all Regulatory CMC commitments from the submitted applications and update the tracking database. * Develop Module 3 templates for Bios. * Work with other team members on the preparation of Module 3 documents as well as tracking of documents. * Perform other duties as assigned. Make Our Values Your Values Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position: * The successful candidate will be enrolled in a Bachelor's degree (or equivalent) program, preferably in the sciences. * Must possess knowledge of general computer systems (ie, Word, Adobe Acrobat, Excel and PowerPoint). * Excellent communication skills, both oral and written