Manager, Medical Writing Quality

Arrowhead Pharmaceuticals•San Diego, CA

7h•$110,000 - $150,000

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. 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 is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead’s standards for accuracy, clarity, compliance, and scientific integrity. The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs.

Requirements

Bachelor’s degree in a medically related or life sciences field with 3–5 years of relevant QC experience in the pharmaceutical industry, or Master’s or doctoral degree with at least 2 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)

Nice To Haves

Familiarity with basic statistical concepts is a plus
Prior experience working with cross-functional study teams

Responsibilities

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 but not limited to 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 kick-off meetings, including slide deck preparation as needed.
Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently.