Senior Manager, Medical Writing

Ultragenyx Pharmaceutical

5h • Remote

About The Position

At Ultragenyx, the vision is to lead the future of rare disease medicine by challenging the status quo and creating a new model that advances the field for patients and caregivers. The company focuses on following science, rapid development, fair pricing, and a collaborative ecosystem. Ultragenyx is committed to a supportive and inclusive culture for employee growth. The Sr Manager, Medical Writing will be responsible for the end-to-end development of various clinical and regulatory documents. This role involves working closely with cross-functional teams to ensure high-quality, timely, and compliant document completion according to SOPs and ICH/GCP/regulatory guidelines.

Requirements

• 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
• 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
• Knowledge of drug development stages, clinical research concepts, regulatory and ICH guidelines as applicable to document writing

Nice To Haves

• at least one eCTD submission strongly preferred
• StartingPoint template, EndNote, Smartsheet, AI tools is a plus
• Rare disease experience is a plus

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

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
• annual bonus
• equity incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Senior