Job Description

ultrafocused – Work together to fearlessly uncover new possibilities

The Associate Director, Medical Writing will be 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 Associate 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 Associate Director will be seen as a key SME for medical writing, providing leadership across global teams.

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 cross-functional input for clinical and regulatory documents including the drafting, editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books
• Ensures smooth, effective, and timely document management from start (template) to finish (approval), which may include: first-draft authoring, literature and reference retrieval, editing, efficient comment resolution, and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) with high quality
• Actively supports cross-functional project teams as the Clinical Regulatory Writing representative, providing input to ensure timely and accurate deliverables and negotiating timelines as necessary
• Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.) and partners with Clinical Trial and Transparency colleges.
• Develops effective collaborative relationships with other key functional stakeholders
• Participates in department initiatives with other Clinical Regulatory Writing members to formulate writing strategies and standards to be implemented and takes responsibility for execution.
• Distills large amounts of clinical and scientific data into essential elements for tabular and graphical display
• Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance.

Requirements:

• BS, MS, or doctorate in a scientific or medical field
• Six+ 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
• Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
• 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
• 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/or gene therapy experience a plus
• Ability and willingness to travel several times a year

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