Medical Writer (Clinical and Regulatory) Remote

Cambridge, MA /
Ultragenyx – Medical Writing /
Full-time
Why Join Us?
Be a hero for our rare disease patients
 
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. 
 
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
 
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. 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 approach will include video discussions, interviews, and 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
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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.