Senior Manager, Medical Writing
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco, and Basel, Switzerland.
The Senior Manager, Medical Writing will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, and other clinical and regulatory documents, including distribution of work to contract medical writers or agencies as needed. This is an individual contributor position with team leadership responsibilities. The Senior Manager, Medical Writing will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, Good Publication Practice, ICH/GCP/regulatory guidelines, and company goals. The core duties of the Senior Director, Medical Writing are delineated below.
Responsibilities, including but not limited to:
- Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses.
- Liaise closely with the Publication Planner to ensure alignment with timelines and data communication plans
- Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions)
- Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
- Distill large amounts of clinical and scientific data into essential elements for graphical display
- Partner with the lead author to oversee document review and comment resolution meetings with cross-functional teams
- Formulate key messages from clinical study data
- Perform literature-based research to support writing activities
- Develop best practices for authoring and reviewing
- Develop and maintain templates and outlines for key documents
- BS, MS, or doctorate in a scientific or medical field
- Three+ years in the biotechnology/pharmaceutical industry preferred
- Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices
- Demonstrated experience in medical writing, editing, and clinical development; previous work on protocols, IBs, CSRs 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
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.