• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases. • Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources. • Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes). • Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text. • Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations. • Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors. • Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones). • Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness. • Contribute to the review and approval of artwork supporting global submissions. • Implement and maintain a quality control measure during all stages of label development. • Maintain knowledge base of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s). • Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business.

Title: Trade Compliance Manager Location: Remote Virginia United States of America Full time This is a fully remote role supporting our BioAnalytical Laboratory in Richmond, VA. We welcome applicants from all locations within the US.   Must be legally authorized to work in the United States without sponsorship.  Must be able to pass a comprehensive background check, which includes a drug screening.    Thermo Fisher Scientific offers the scale, reach, and mission-driven work to make a meaningful impact. As a Trade Compliance Manager, you will manage the trade compliance and import/export strategy for clinical trial samples and reference standard material for assigned studies, ensuring that activities are in full compliance with applicable local regulations, company requirements and client needs.   What You'll Do: - Develop Trade Compliance Import/Export strategy for each assigned study - Ensure proficient communication and interaction with internal and external stakeholders to coordinate efforts, provide recommendations, and issue alerts to avoid obstacles during the import/export processes - Ensure assigned studies are always in compliance with Trade Compliance, local regulations, company requirements and client needs - Serve as the primary point of contact and escalation for Trade Compliance and Import/Export matters for assigned studies - Stay up to date with new processes and regulations concerning Trade Compliance and Import/Export - Participate in process improvement initiatives - Represent the Trade Compliance and Import/Export department as a primary point of contact and escalation for assigned studies - Interact with internal and external personnel on significant matters, often requiring coordination between functional areas - Work on problems of diverse scope, requiring the analysis of data and evaluation of various elements   Education and Experience: - Bachelor's degree or equivalent and relevant formal academic/vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) - Prior experience in clinical research, specifically in clinical supplies import/export, is highly preferred - In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role   Knowledge, Skills, and Abilities: - Strong understanding of import/export operations, local and global regulations and clinical trial supply operations - Strong interpersonal, planning, organizational, problem-solving and decision-making skills - Strong understanding of the Microsoft Office suite - Strong focus on customers and attention to detail - Ability to work as team, as well as work independently with moderate mentorship - Fluency in English (reading, writing and speaking)   Working Conditions and Environment: - Work is performed in a home-based environment with exposure to electrical office equipment - High pressure and intense concentration on a daily basis - Close attention to detail - Constant multi-tasking - Daily interaction with clients/associates - Long, varied hours on an occasional basis

Role Description The Director of Compliance Investigations is responsible for leading the investigations team, managing allegations of Compliance policy violations, and ensuring all necessary corrective actions are taken to maintain an effective Compliance program. This role requires a forward-thinking leader who can drive process improvements and leverage technology to support compliance activities. This role may work remotely but near site in New York, New Jersey or Pennsylvania. National base range $160,000 - $180,000 but actual compensation dependent on location + 20% AIP. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation. Qualifications - Experience in compliance investigations. - Strong leadership skills. - Ability to drive process improvements. - Proficiency in leveraging technology for compliance activities. Requirements - Manage allegations of Compliance policy violations. - Ensure corrective actions are taken. Benefits - Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours. - Best-in-class well-being programs. - Annual, no-cost health assessment program Blueprint for Wellness®. - healthyMINDS mental health program. - Vacation and Health/Flex Time. - 6 Holidays plus 1 "MyDay" off. - FinFit financial coaching and services. - 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service. - Employee stock purchase plan. - Life and disability insurance, plus buy-up option. - Flexible Spending Accounts. - Annual incentive plans. - Matching gifts program. - Education assistance through MyQuest for Education. - Career advancement opportunities. - …and so much more!

• Remotely sign documents for bank account openings • Support ongoing corporate compliance as required