Medical Writer na Ultragenyx Pharmaceutical
Ultragenyx Pharmaceutical · Remote, Estados Unidos Da América · Remote
Position Summary:
ultradedicated – Your biggest challenges yield rare possibilities
The Medical Writer is responsible for 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 or MS with 0-2+ years in the biotechnology/pharmaceutical industry or advanced degree/PhD in a scientific or medical field
- 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
- Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
- 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
- Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)
- Rare disease experience a plus
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Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
