Summer Intern, Medical Writing

Arrowhead Pharmaceuticals•San Diego, CA

1d•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 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.

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.

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.