Director, Medical Writing

Ultragenyx Pharmaceutical

11h•Remote

About The Position

The Director Medical Writing is an expert medical writer, 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 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 Director Medical Writing will manage and mentor more junior writers. The Director will be seen as a key SME for medical writing providing leadership across global teams. The core duties of the Director Medical Writing are delineated below.

Requirements

BS, MS, or doctorate in a scientific or medical field with 10 years working as a medical writer in the biotechnology/pharmaceutical industry (advanced degree preferred)
Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission
Deep understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, NDAs/BLAs and MAAs.
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 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, and experience working successfully on matrixed teams
Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels

Nice To Haves

Rare disease experience and a strong understanding of metabolic genetics or metabolic bone disease a plus

Responsibilities

Development and implementation of document strategy for clinical and regulatory documents including the writing, editing and/or reviewing of protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, and briefing books
Develop and maintain a strong network of internal relationships to actively support cross functional project team(s) representing Clinical Regulatory Writing
Provides strategic insight for timely and accurate deliverables, negotiating timelines as necessary
Drives and executes writing strategies across clinical development program(s) ensuring effective collaborations with other functional areas
Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives and/or contract writers as required and ensure adherence to standards
Effectively manages vendor/contract writers and forecasts external resources as needed to support internal deliverables
Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.)
Provides coaching, training, and supervision of medical writing staff as applicable
Provides department leadership by proposing and overseeing new initiatives and capabilities
Work across departments to help set priorities and establish best practices for document preparation and review.
Manages resource planning including program and team forecasting