What are the responsibilities and job description for the Summer Intern - Regulatory Affairs position at Harmony Biosciences?
At Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases that others often overlook. We believe that where empathy and innovation meet, a better life can begin for people living with neurological diseases. Our team of experts from a wide variety of disciplines and experiences is driven by our shared conviction that innovative science translates into therapeutic possibilities for patients, who are at the heart of everything we do.
Harmony Biosciences culture is defined by our core values - keeping patients at the heart of all we do, acting with integrity and ethics, working with a one-team attitude, leading with the science as we identify clinical possibilities, and delivering excellence.
This summer internship at Harmony offers a unique perspective into a rare-disease focused biotech company. Our internship program will provide you the opportunity to work on real-world projects, as well as network with people at Harmony through various events and activities.
Summary of Internship:
This position will work with the Regulatory Affairs (RA) team at Harmony. The RA team is responsible for ensuring accurate data are submitted to the US Food and Drug Administration (FDA) in a timely manner and interacting with FDA on research and development programs and initiatives. The RA team also collaborates with internal cross-functional departments to provide regulatory strategy and expertise in accordance with US FDA requirements and industry best practices.
Key Responsibilities include, but are not limited to:
- Assist with migration and implementation activities for the Regulatory Information Management (RIM) system.
- Participatein cross-functional meetings and contribute to deliverables related to research and development initiatives, including for clinical studies; Chemistry, Manufacturing and Controls (CMC); promotional materials; and regulatory strategy.
- Assist with regulatory submissions and activities, including but not limited to review and submission of clinical study reports, study protocols, protocol amendments, and regulatory information amendments.
- Work with assigned mentors on projects to stimulate problem solving and critical thinking skills.
- Assist with other projects as needed to support the regulatory team.
Requirements:
- Minimum age for all candidates must be at least 18 years or older.
- Must be enrolled in an accredited college or university as a rising sophomore, junior or senior majoring in science or engineering.
- Must be proficient in use of MS Excel, MS Power Point, MS Teams
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.
- Candidates must have strong written and verbal communication skills.
PHYSICAL DEMANDS AND WORK ENVIORNMENT:
- While performing the duties of this job, the noise level in the work environment is usually quiet.
- Specific vision abilities required by this job include - Close vision.
- Manual dexterity required to use computers, tablets, and cell phone.
- Continuous sitting for prolonged periods.
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Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.