Medical Writer (Clinical and Regulatory)

31 Dec, 2020

Jobs

Medical Writer (Clinical and Regulatory)

Ultragenyx
Cambridge, MA
Why Join Us?
Be a hero for our rare disease patients
 
Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.
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! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding.
Position Summary
ultraimpact – Make a difference for those who need it most
The Senior Manager (Clinical and Regulatory), Medical Writing will be responsible for writing and overseeing the writing of various clinical and regulatory documents. This person 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. This is an independent contributor position. The core duties of the Senior Manager, Medical Writing are delineated below.

Responsibilities including, but not limited to:

    • Write, edit, or collaborate on development of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
    • 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 as required and ensure adherence to standards
    • Distill large amounts of clinical and scientific data into essential elements for graphical display
    • 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

Requirements:

    • BS, MS, or doctorate in a scientific or medical field
    • 3+ years in the biotechnology/pharmaceutical industry preferred
    • Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs
    • Familiar with eCTD structure, and experience with eCTD summary documents (e.g., Modules 2.5 and 2.7) and/or regulatory briefing documents a plus
    • 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
    • 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 and gene therapy a plus
#LI-TR1
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. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
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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 totalentacquisition@ultragenyx.com.
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Job posted: 2020-12-31