Associate Director, Medical Writing – Clinical and Regulatory

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $188.9k - $233.3k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• 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

🏖️ Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans