The Director Medical Writing is an expert medical writer, responsible for writing and coordinating the writing of various clinical and regulatory documents including protocols/amendments, investigator brochures, clinical study reports, and NDA/BLA submission documents. The Director Medical Writing will work closely with cross-functional teams to manage the preparation of written clinical and regulatory documents, ensuring that they are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Director Medical Writing will manage and mentor more junior writers. The Director will be seen as a key SME for medical writing providing leadership across global teams. The core duties of the Director Medical Writing are delineated below.

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:

• Development and implementation of document strategy for clinical and regulatory documents including the writing, editing and/or reviewing of protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, and briefing books
• Develop and maintain a strong network of internal relationships to actively support cross-functional project team(s) representing Clinical Regulatory Writing
• Provides strategic insight for timely and accurate deliverables, negotiating timelines as necessary
• Drives and executes writing strategies across clinical development program(s) ensuring effective collaborations with other functional areas
• Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives and/or contract writers as required and ensure adherence to standards
• Effectively manages vendor/contract writers and forecasts external resources as needed to support internal deliverables
• Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.)
• Provides coaching, training, and supervision of medical writing staff as applicable
• Provides department leadership by proposing and overseeing new initiatives and capabilities
• Work across departments to help set priorities and establish best practices for document preparation and review.
• Manages resource planning including program and team forecasting

Requirements:

• BS, MS, or doctorate in a scientific or medical field with 10 years working as a medical writer in the biotechnology/pharmaceutical industry (advanced degree preferred)
• Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission
• Deep understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, NDAs/BLAs and MAAs.
• 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, Adobe Illustrator, figures and graphic design; Project and Visio a plus)
• Ability to build and maintain effective partnerships, both internally and externally, and experience working successfully on matrixed teams
• 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 or metabolic bone disease a plus #LI-CS1 #LI-Remote