Junior Regulatory Affairs Associate

Junior Regulatory Affairs Associate

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:
Project Administration:

• Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.
• Provide basic regulatory affairs services including preparing submission packages Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

Document Management:

• Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
• Develop a familiarity with current global regulatory submission standards.

Standard Operating Procedures:

• Develop a familiarity with departmental standard operating procedures and work instructions.

Product Support:

• (Regulatory Affairs only) Under supervision provide support to currently marketed products.

Skills:
Project Execution:

• Works effectively within a team environment.
• Works within broad project guidelines as directed by the project Technical Lead or Project Manager.
• With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritize work to achieve specified project outcomes.
• Capitalizes on opportunities to improve performance and seeks feedback from the project Team Lead and colleagues.
• Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities.
• Produces quality work that meets the expectations of Project Lead and the client.

Relationship Management:

• Completes assigned activities within project scope and objectives under the direction of the Project Lead.
• Identifies project and internal issues to senior colleagues and Project Lead.
• Interacts professionally at all working levels within a client organization and within Parexel.
• Identifies project and/or client needs to the Project Lead.

Parexel-Related Responsibilities:

• Meets established metrics as specified in scorecard on an annual basis.
• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management.
• Defines self-development activities with the support of management to keep current within the industry.

Knowledge and Experience:

• 0-2 years’ experience in an industry-related environment.

Education:

• Bachelor’s Degree in a Scientific or Technical Discipline.

Experience Level

Entry Level