Ultragenyxpharmaceutical
Associate Director, Medical Writing (Clinical and Regulatory)
United States - Remote · Director · Full-time
Sponsorship not specified$189k-$233kDetected 17 hours ago
GCPComplianceIllustratorGraphic DesignProject ManagementHRCRISPRLeadershipCommunicationMicrosoft Office
About the role
- ultra focused - Work together to fearlessly uncover new possibilities
- The Associate Director will be seen as a key SME for medical writing, providing leadership across global teams.
- Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities
- 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
- 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
- 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
- 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.
- Develops effective collaborative relationships with other key functional stakeholders
- 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.
Requirements
- Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
- Strong organizational abilities and experience in a multitasking environment
Nice to have
- worked on at least one eCTD/NDA submission a plus.
- has written protocols, IBs, CSRs
- Project and Visio a plus)
- Rare disease experience and/or gene therapy experience a plus
Compensation
- $188,900 - $233,300 USD
- Long term incentive and Employee stock purchase plans or equivalent offerings
Benefits
- 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 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.
- Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance.
- Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
Company info
- 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.
Equal opportunity
- 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.
Apply directly at Ultragenyxpharmaceutical →Create a free account for alerts like thisView Ultragenyxpharmaceutical immigration profile
This listing is sourced directly from Ultragenyxpharmaceutical's careers page and normalized into a canonical job model.