Junior Regulatory Affairs Associate One year contract
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Job Location:
Petaling Jaya - Malaysia
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were 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:
- Bachelors Degree in a Scientific or Technical Discipline.
Required Experience:
Junior IC
Key Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
