Medical Writer (Clinical and Regulatory)

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. Position Summary: The Medical Writer is responsible for writing and overseeing the writing of various clinical and regulatory documents. The position works closely with the cross-functional team to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The core duties of the medical writing manager are delineated below. ultradedicated – Your biggest challenges yield rare possibilities Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities: Responsibilities, 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 • Partnering with lead author, 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 and maintain templates and outlines for key documents Requirements: • * BS, MS, or doctorate in a scientific or medical field • Two+ years in the biotechnology/pharmaceutical industry 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 • Proven ability to 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 • Rare disease experience or a strong understanding of metabolic bone disease a plus #LI-DNI The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range $109,800—$135,700 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · 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 • Benefits vary by region and country Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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 to: talentacquisition@ultragenyx.com. Apply tot his job Apply To this Job