Medical Writer (Clinical and Regulatory)
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.
ultradedicated - Your biggest challenges yield rare possibilities
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:
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
#LI-DNI
Apply Now
Apply Now
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.
ultradedicated - Your biggest challenges yield rare possibilities
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:
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
#LI-DNI
Apply Now
Apply Now