Medical Writing Intern
The Position
The Medical Writing Intern will support Regulatory and Medical Writing activities at Arrowhead Pharmaceuticals by contributing to preparation of a supplemental New Drug Application (sNDA) and related clinical documentation. This internship offers hands-on exposure to regulatory writing, clinical study reports (CSRs), and submission workflows while working alongside experienced medical writers. The intern will gain practical experience compiling, reviewing, and organizing data that supports high-quality regulatory submissions.
This is an 11-week Summer Internship Program paying $24.00 per hour and requires full-time, onsite work five days per week at the designated location.
Responsibilities
- Assist with storyboard development for sNDA clinical studies
- Support data reviews of statistical tables, figures, and listings (TFLs).
- Assist with technical aspects of Clinical Study Report (CSR) content, including data verification and formatting.
- Support module development activities for the sNDA submission.
- Assist with data entry and compilation within sNDA modules.
- Learn the fundamentals of NDA and sNDA structure, content, and regulatory requirements.
- Collaborate with lead medical writers and cross-functional team members to support submission timelines.
Requirements:
- Currently enrolled student at an Accredited University or College and majoring in a scientific discipline
- Strong interest in medical writing, regulatory affairs, or clinical development.
- Excellent written and verbal communication skills.
- Strong attention to detail and organizational skills.
- Coursework or experience related to clinical research, regulatory affairs, or scientific writing.
- Proficiency in Microsoft Office applications.
- Familiarity with clinical trial data or CSRs.
- Strong proofreading and editing skills.
- Interest in pursuing a career in medical writing or regulatory submissions
- Ability to manage multiple tasks and meet deadlines.