Ultragenyx

Medical Writer (Clinical and Regulatory)

Ultragenyx

full-time

Posted on:

Origin:  • 🇺🇸 United States

Visit company website
✨ AI Apply
Manual Apply

Salary

💰 $109,800 - $135,700 per year

Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • 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.
  • 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:
  • 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