Director, Medical Writing

July 26

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Ultragenyx

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Rare mission. Fearless team. Incredible possibilities.

rare disease • ultra-rare disease

501 - 1000

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, 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.

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

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