Undergrad Intern - Regulatory Affairs (Obesity)

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Undergrad Intern - Regulatory Affairs (Obesity)

This could be your everyday

Lets do this. Lets change the world. During this program, you will be responsible for providing administrative for the Regulatory Affairs Director and supporting the execution of US regulatory submissions compliance with corporate standards and regulatory requirements.

Key responsibilities include:

• Support the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
• Assist Global Regulatory Lead(s) manage GRT interactions
• Assist US Regulatory Lead(s) with local regulatory activities (e.g. IND submissions and agency meetings)
• Support US Regulatory Lead(s) maintain CTA/MA documentation (e.g. initial filings, amendments, and periodic reports)
• Maintain product regulatory information and history documents through Amgen systems
• Appropriately archive regulatory documents and agency communications
• Support CROs / partners to support site initiation
• Assist regulatory form completion to support agency communications
• Provide regulatory support through cross-functional interactions in work package teams (eg. commercial and evidence generation teams)
• Support the development and execution of GRT goals

Heres what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The passionate and driven individual we seek is a collaborative team player with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelors Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelors degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship OR co-op

Preferred Qualifications

• Degree concentration(s) in Biology, Chemistry, Biotechnology, Environmental or Occupational Health, Life Science, Toxicology, Public Health, Nursing, Biomechanics/Ergonomics, Political Science OR related field
• Desire to learn the regulatory affairs field and support US regulatory submissions in compliance with corporate standards and regulatory requirements
• Ability to lead and deliver results in an interactive matrixed environment
• Strong written and oral communication skills, relationship building, and leadership skills
• Experience with general office software applications (MS Word, Excel, PowerPoint, etc.)
• Able to manage time efficiently and work with minimum supervision

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional youre inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply nowfor an internship/co-op that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

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In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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