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Arrowhead Pharmaceuticals · 4 weeks ago

Manager, Medical Writing Quality

San Diego, California, United States

Full-time

Onsite

Mid, Senior Level

$110K/yr - $150K/yr

3+ years exp

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for genetic diseases. The Manager, Medical Writing Quality will lead the QC function for clinical and regulatory documents, ensuring they meet high standards for accuracy and compliance.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Quality Control experienceMedical writing experienceFDA regulationsDocument management systemsCollaboration tools proficiencyStatistical concepts familiarityAttention to detailCross-functional teamwork

Required

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)

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