Associate Director, Medical Writing

Location
Novato, California or Brisbane, California
Posted
Aug 17, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Why Join Us?

To be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy 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. 

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Associate Director, Medical Writing will be responsible for writing and overseeing the writing of various 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 Associate Director, Medical Writing will work closely with cross-functional teams to ensure the documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.  The core duties of the Associate Director, Medical Writing are delineated below.

Responsibilities, including but not limited to:

  • Write, edit, or collaborate on development of high-quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
  • Contribute scientifically and strategically and lead submission-level activities for writing team
  • Ensure smooth and effective document management from start to finish (i.e., from template 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)
  • 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
  • Distill large amounts of clinical and scientific data into essential elements for graphical display
  • Partnering with lead author,  oversee document review and comment resolution meetings with cross-functional teams
  • May 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.
  • 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

Requirements:

  • BS, MS, or doctorate in a scientific or medical field
  • Six+ years in the biotechnology/pharmaceutical industry including in-house experience preferred
  • Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission 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
  • Experience analyzing and communicating scientific data in peer-reviewed scientific publications and knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices a plus
  • Rare disease experience and/or experience in bone disease a plus

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.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will  not create any implied obligation.  Inquiries on developing a recruiting relationship with us, may be directed tohr@ultragenyx.com.