Intern, Regulatory Project Management - Brisbane City, Australia - Ultragenyx Pharmaceutical Inc.

Description

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 andpersonally, come join our team.

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

We are looking for a dedicated Regulatory Project Management Intern with an innovation mindset and an interest in drug development to join our Global Regulatory Affairs Department. Regulatory Affairs is involved in all stages of drug development and is responsible for obtaining and maintaining global approvals for pharmaceutical products. Regulatory Affairs also interacts with global health authority agencies to communicate, engage, and collaborate on global drug development and health policies. This ensures pharmaceutical products are safe, effective, and meet regulatory standards.

In this role, you will develop, implement, and optimize regulatory tools and templates. You will use project management and data visualization software (e.g. Smartsheet, PowerBI, etc.) to streamline and enhance our regulatory processes. This helps create efficiencies and drive communication of regulatory information. You will gain hands-on experience in utilizing project management software within a regulatory environment and have the opportunity to present at a summer internship showcase.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Develop and optimize Smartsheet tools and templates to facilitate regulatory project and portfolio tracking, resource management, data visualization, and automation workflows. You will work with the hiring manager to define the scope of the project, specific deliverables, and goals.
• Interview subject matter experts to understand specific needs and challenges while developing project management tools.
• Identify opportunities for process and tool improvements and propose solutions to enhance efficiencies.
• Ensure data entry and maintenance processes within the newly developed tools are implemented and reliable to provide accurate tracking and metrics.
• Implement automation features to streamline tasks and status updates within Smartsheet.
• Develop and customize reports and dashboards to provide visibility into regulatory information.
• Present regular updates on project status to regulatory project management team and other stakeholders as needed.
• Conduct user testing to get feedback on the developed regulatory project management tools and templates. If needed, develop training materials.
• Assist in the implementation of new regulatory project management processes within the department.

Requirements:

• Pursuing a Bachelor's or Master's degree in a relevant field of study (Life Sciences preferred), with minimum of second/sophomore year completed if pursuing a Bachelor's degree.
• Enrolled as a full-time student with plans to return to school in fall term
• Available to work 40 hours/week during normal business hours
• Knowledgeable of Microsoft Office Suite (Word, Excel, PowerPoint). Advanced MS Excel expertise is a plus.
• Direct experience with or willingness to learn Smartsheet and other related software.
• Strong organizational skills
• Flexible; adapts work style to meet organization needs
• Meticulous attention to detail
• Strong ability to follow through with tasks
• Good verbal communication skills: Ability to write clearly and effectively
• Ability to exercise sound judgment, reasoning, and problem solving
• Capable of completing assigned responsibilities and keeping manager informed of work status
• Demonstrated innovation mindset and self-motivation in previous project(s)
• Proven to work both independently and collaboratively
• Displayed the ability to identify issues and seek solutions
• Interested in learning about how regulatory and project management interface to support drug development.

· Generous vacation time and public holidays observed by the company

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Fitness reimbursement

* 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

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: .

Accepted file types: pdf, doc, docx, txt, rtf

Accepted file types: pdf, doc, docx, txt, rtf

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