Associate Director, Medical Writing

Novato, CA or Brisbane, CA
Ultragenyx – Program & Portfolio Management
Full-time

Why Join Us?
 
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.  
 
Come join our team during this exciting time of growth and opportunities!
 
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco, and Basel, Switzerland.

Position Summary:

The Associate Director, Medical Writing will be responsible for writing and overseeing the writing of various clinical and regulatory documents, including distribution of work to contract medical writers or agencies as needed. This is an individual contributor position with team leadership responsibilities. The Associate Director, Medical Writing will work closely with cross-functional teams to ensure the documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.  The core duties of the Associate Director, Medical Writing are delineated below.

Responsibilities, including but not limited to:

    • Write, edit, or collaborate on development of high-quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
    • Contribute scientifically and strategically and lead submission-level activities for writing team
    • 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 and/or contract writers 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
    • May interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses.
    • Formulate key messages from clinical study data
    • Perform literature-based research to support writing activities
    • Develop best practices for authoring and reviewing
    • Develop and maintain templates and outlines for key documents

Requirements:

    • BS, MS, or doctorate in a scientific or medical field
    • Six+ years in the biotechnology/pharmaceutical industry including in-house experience 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
    • Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
    • Experience analyzing and communicating scientific data in peer-reviewed scientific publications and knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices a plus
    • Rare disease experience and/or experience in bone disease a plus

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

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