• Job Description

  Req#: 5319

  The intern will work alongside experienced professionals, gaining insight into regulatory compliance and clinical study oversight.

  Key Responsibilities:

  • Support project management, including tracking action items and project milestones.
  • Assist with the management of databases related to project strategies, clinical studies, and investigator audits.
  • Contribute to authoring regulatory submissions, including meeting requests, controlled correspondence, and PADERs (Periodic Adverse Drug Experience Reports).
  • Assist in the organization and tracking of clinical study documentation.
  • Collaborate with teams to ensure regulatory compliance and data accuracy.

  Qualifications & Skills:

  • Currently pursuing a degree in Clinical Research, Regulatory Affairs, Pharmaceutical Sciences, or Chemistry.
  • Completed coursework related to the areas of study above.
  • Proficiency in Microsoft Office Suite.
  • Strong computer skills, including database management.
  • Excellent communication, teamwork, and organizational skills.

  Benefits of the Internship:

  • Gain hands-on experience in regulatory affairs and clinical research.
  • Work alongside industry professionals and expand your professional network.
  • Develop skills in regulatory compliance, project management, and clinical documentation.

  Qualifications

  Education:

  • High School diploma or GED—Required
  • Current full-time enrollment in an accredited college or university undergraduate or graduate program—Required
  • Minimum cumulative GPA of 3.0—Required

  Additional Requirements:

  • Must be at least 18 years old.
  • Must be legally authorized to work in the United States.
  • Must commit to the full 10-12-week duration of the internship.

  To be considered, candidates must meet all the above criteria.

• About the company

  Amneal Pharmaceuticals, Inc. is an American domiciled publicly traded generics and specialty pharmaceutical company.

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