Medical Writer, Medical Writing

Ultragenyx Pharmaceuticals Brisbane , CA 94005

Posted 1 week ago

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary

ultrafocused Work together to fearlessly uncover new possibilities

The Medical Writer is responsible for writing and overseeing the writing of peer-reviewed scientific publications, and other clinical and regulatory documents. This is an individual contributor position. The medical writer works closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, Good Publication Practice, ICH/GCP/regulatory guidelines, and company goals. The core duties of the medical writer are delineated below.

Responsibilities including, but not limited to:

  • 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.

  • Liaise closely with the Publication Planner to ensure alignment with timelines and data communication plans.

  • May write clinical study reports, investigator brochures, protocols, protocol amendments, and regulatory submission documents

  • May provide on-site scientific congress support

  • Communicate and collaborate with multiple functions across the organization

  • Act as a functional area representative on development subteams

  • Ensure smooth and effective document management from start to finish (i.e., generation of a blank document 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, journal and congress submissions)

  • Distill large amounts of clinical and scientific data into essential elements for graphical display

  • Partner with the lead author to 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

Technical Requirements &

Skills:
  • BS, MS, or doctorate in a scientific or medical field

  • Two+ years in the biotechnology/pharmaceutical industry preferred

  • Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices

  • Demonstrated experience in medical writing, editing, and clinical development

  • 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 in rare or metabolic diseases a plus

  • 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

  • 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 bone disease or metabolic genetics a plus

Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.

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Medical Writer, Medical Writing

Ultragenyx Pharmaceuticals