Director, Medical Writing

Role Description

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
• 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 will also manage and mentor more junior writers and will be seen as a key SME for medical writing providing leadership across global teams.

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

• Development and implementation of document strategy for clinical and regulatory documents including 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.

Qualifications

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

Requirements

• The typical annual salary range for this full-time position is $207,600 — $256,400 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.