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Jobs at Parexel

Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Junior Regulatory Affairs Associate (One year contract)

Job ID R0000039071 Petaling Jaya, Selangor, Malaysia

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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