Medical Writer - Novato, CA | Biospace
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Medical Writer

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
8/10/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Medical Writer,

Job Description


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.

Position Summary:

The Medical Writer is responsible for writing and overseeing the writing of various clinical and regulatory documents. The position works 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.

Responsibilities, but not limited to:
•   Write, edit, or collaborate on development of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
•   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 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
•   Formulate key messages from clinical study data
•   Perform literature-based research to support writing activities
•   Develop and maintain templates and outlines for key documents

Requirements


•   BS, MS, or doctorate in a scientific or medical field
•   Two+ years in the biotechnology/pharmaceutical industry 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
•   Proven ability to 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
•   Rare disease experience or a strong understanding of metabolic 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.