[Hiring] Senior Manager, Medical Writing @Ultragenyx Pharmaceutical

Role Description

The Sr Manager, Medical Writing will be responsible for the end-to-end development of various clinical and regulatory documents. The Sr Manager, Medical Writing will work closely with cross-functional teams to develop content and ensure documents are of high quality and completed in a timely manner compliant with SOPs and ICH/GCP/regulatory guidelines.

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:

• Leads/supports development (including authoring, editing, coordinating reviews, QC, finalization) of clinical and regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, eCTD clinical summaries, briefing books, IRs).
• Drives cross-functional collaboration in the preparation of clinical and regulatory documents, including alignment on content and messaging, effective conduct of roundtable meetings, resolution of feedback/comments.
• Distills large amounts of clinical and scientific data into clear, consistent messaging that aligns with program strategy.
• Adheres to departmental procedures and practices and applies ICH/GCP/regulatory guidelines and industry standards to document development.
• Contributes to developing/implementing processes and best practices within the Clinical and Regulatory Writing department.
• Represents Clinical and Regulatory Writing department on various cross-functional teams.

Qualifications

• BS or MS in a scientific or medical field.
• 5+ years of relevant medical writing experience in the biotechnology/pharmaceutical industry.
• Demonstrated experience in development of clinical and regulatory documents; at least one eCTD submission strongly preferred.
• Ability to interpret and create complex tabular and graphical clinical data presentations.
• Exceptional oral and written communication skills.
• Capable of working on multiple tasks and shifting priorities.
• Demonstrated flexibility and adaptability to changing strategy and timelines.
• Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals.
• Demonstrated proficiency and experience with Microsoft Office Suite and Veeva Vault; StartingPoint template, EndNote, Smartsheet, AI tools is a plus.
• Knowledge of drug development stages, clinical research concepts, regulatory and ICH guidelines as applicable to document writing.
• Rare disease experience is a plus.

Requirements

• The typical annual salary range for this full-time position is $170,200 — $210,200 USD.
• This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Benefits

• Generous vacation time and public holidays observed by the company.
• Volunteer days.
• Long term incentive and Employee stock purchase plans or equivalent offerings.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.
• Benefits vary by region and country.