Preferred Degree: Unspecified
Job Type: Part Time
Experience (Years): 4-6
Job Category: Clinical Development/Affairs
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain global commercialization rights to our products.
Come join our team during this exciting time of growth! We are located in Novato, CA just 28 miles north of San Francisco.
Looking for availability of 20 to 30 hours a week. Reporting to the Director, Medical Writing the ideal candidate will be responsible for writing various clinical and regulatory documents, will work 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.
• Write clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, safety reports, INDs, eCTD/NDA clinical summaries, briefing books)
• Ensure smooth and effective document management from start to finish (i.e., generation of a blank document 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 other writers or 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 in house medical writing staff and clinical lead, 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
• BS, MS, or doctorate in a scientific or medical field
• Five+ years in the biotechnology/pharmaceutical industry 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 develop and 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, figures and graphic design)
• Ability to build and maintain effective partnerships, both internally and externally
• Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels
• Rare disease experience and a strong understanding of metabolic genetics a plus