Remote Director Medical Writing

Summary

Join our team at Ultragenyx, a biopharma company that believes in taking real impactful action to care for the needs of patients and people. We're looking for a Director Medical Writing to lead our clinical and regulatory writing efforts.

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

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

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