Intern, Regulatory Project Management

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.