Junior Regulatory Affairs Associate
4 weeks ago
When our values align, there's no limit to what we can achieve.
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.
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