Medical Writer (Clinical and Regulatory)

Position Summary: The Medical Writer is responsible for writing and overseeing the writing of various clinical and regulatory documents. The position works closely with the cross-functional team to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The core duties of the medical writing manager are delineated below. ultradedicated - Your biggest challenges yield rare possibilities Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities: Responsibilities, but not limited to: • Write, edit, or collaborate on development of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books) • Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) • Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards • Distill large amounts of clinical and scientific data into essential elements for graphical display • Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams • Formulate key messages from clinical study data • Perform literature-based research to support writing activities • Develop and maintain templates and outlines for key documents Requirements: • * BS, MS, or doctorate in a scientific or medical field • Two+ years in the biotechnology/pharmaceutical industry preferred • Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus. • Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support • Proven ability to implement medical writing processes and standards • Exceptional oral and written communication skills • Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues • Flexible; adapts work style to meet organization needs • Strong organizational abilities and experience in a multitasking environment • Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals • Dedication to quality and reliability • Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus) • Ability to build and maintain effective partnerships, both internally and externally • Rare disease experience or a strong understanding of metabolic bone disease a plus #LI-DNI Apply tot his job Apply To this Job