Associate Director, Medical Writing (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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Associate Director, Medical Writing will be responsible for writing and coordinating the writing of various clinical and regulatory documents, including protocols/amendments, investigator brochures, clinical study reports, and NDA/BLA submission documents. The Associate Director, Medical Writing will work closely with cross-functional teams to manage the preparation of written clinical and regulatory documents, ensuring that they are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Associate Director will be seen as a key SME for medical writing, providing leadership across global teams.

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:

1. Development and implementation of cross-functional input for clinical and regulatory documents including the drafting, editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books

2. Ensures smooth, effective, and timely document management from start (template) to finish (approval), which may include: first-draft authoring, literature and reference retrieval, editing, efficient comment resolution, and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) with high quality

3. Actively supports cross-functional project teams as the Clinical Regulatory Writing representative, providing input to ensure timely and accurate deliverables and negotiating timelines as necessary

4. Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.) and partners with Clinical Trial and Transparency colleges.

5. Develops effective collaborative relationships with other key functional stakeholders

6. Participates in department initiatives with other Clinical Regulatory Writing members to formulate writing strategies and standards to be implemented and takes responsibility for execution.

7. Distills large amounts of clinical and scientific data into essential elements for tabular and graphical display

8. Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance.

Requirements:

1. BS, MS, or doctorate in a scientific or medical field

2. Six+ years in the biotechnology/pharmaceutical industry

3. Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus.

4. Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support

5. Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects

6. Proven ability to develop and implement medical writing processes and standards

7. Exceptional oral and written communication skills

8. Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues

9. Flexible; adapts work style to meet organization needs

10. Strong organizational abilities and experience in a multitasking environment

11. Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals

12. Dedication to quality and reliability

13. Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)

14. Ability to build and maintain effective partnerships, both internally and externally

15. Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels

16. Rare disease experience and/or gene therapy experience a plus

17. Ability and willingness to travel several times a year

#LI-CS1 #LI-Remote

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$188,900—$233,300 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.

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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.