Associate Director, Medical Writing (Clinical and Regulatory)

Ultragenyx Pharmaceutical

1d•$188,900 - $233,300•Remote

About The Position

The Associate Director, Medical Writing will be responsible for writing and coordinating the writing of various clinical and regulatory documents, including protocols/amendments, investigator brochures, clinical study reports, and NDA/BLA submission documents. The Associate Director, Medical Writing will work closely with cross-functional teams to manage the preparation of written clinical and regulatory documents, ensuring that they are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Associate Director will be seen as a key SME for medical writing, providing leadership across global teams.

Requirements

BS, MS, or doctorate in a scientific or medical field
Six+ years in the biotechnology/pharmaceutical industry
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
Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
Proven ability to develop and 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
Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels
Ability and willingness to travel several times a year

Nice To Haves

Rare disease experience and/or gene therapy experience a plus

Responsibilities

Development and implementation of cross-functional input for clinical and regulatory documents including the drafting, editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books
Ensures smooth, effective, and timely document management from start (template) to finish (approval), which may include: first-draft authoring, literature and reference retrieval, editing, efficient comment resolution, and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) with high quality
Actively supports cross-functional project teams as the Clinical Regulatory Writing representative, providing input to ensure timely and accurate deliverables and negotiating timelines as necessary
Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.) and partners with Clinical Trial and Transparency colleges.
Develops effective collaborative relationships with other key functional stakeholders
Participates in department initiatives with other Clinical Regulatory Writing members to formulate writing strategies and standards to be implemented and takes responsibility for execution.
Distills large amounts of clinical and scientific data into essential elements for tabular and graphical display
Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance.