Manager, Medical Writing Quality

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company developing 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.

Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role will partner closely with medical writing colleagues and cross‑functional subject matter experts to oversee QC activities for Medical Writing deliverables and coordinate external QC services.

• Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas.
• Perform QC activities (editing and data verification) for clinical and regulatory documents, including clinical study protocols and amendments, Investigator’s Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books.
• Collaborate with lead medical writers and subject matter experts to identify and obtain appropriate QC source materials.
• Manage external QC vendors to ensure consistent, high‑quality deliverables when additional support is required.
• Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead’s expanding pipeline.
• Support planning and content development for document kickoff meetings, including slide deck preparation as needed.
• Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently.

• Bachelor’s degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master’s or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry.
• Exceptional attention to detail, with the ability to identify issues in complex scientific documents.
• Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing.
• Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments.
• Ability to manage multiple priorities while maintaining high‑quality standards.
• Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint).
• Familiarity with basic statistical concepts is a plus.
• Prior experience working with cross‑functional study teams.

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.