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Regulatory Affairs Associate

Parexel339 open roles

Where
Malaysia-Petaling Jaya
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Your applicationOpen nowRegulatory Affairs AssociateParexel · Malaysia-Petaling Jaya
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The clock on this job

Early applications get read.

13.9% of postings close within 7 days. Measured by our own scanner across the market. Parexel postings stay open a median of 20 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.9%7 days
  4. 22.4%14 days
  5. 38.1%30 days
  6. 59.0%60 days
This job: posted today

Parexel median: 20 days open

The posting

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 Execution

  • Works effectively within a team environment
  • Works within broad project guidelines as directed by the Project Lead or Technical SME
  • With the guidance of the project Technical SME, demonstrates the ability to prioritize work to achieve specified project outcomes
  • Capitalizes on opportunities to improve one’s own performance and seeks feedback from the Project Lead and colleagues
  • Applies information provided by the Project Lead or senior colleagues to complete assigned project activities
  • Produces quality work that meets the expectations of project lead and the client
  • May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects
  • When serving as a Project Lead with clear guidance and support from Line Manager
  • Responsible for project planning and set-up and routinely
  • interacts with the assigned Project Specialist (PS) or Project
  • Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)
  • Functions as the main client contact and ensures accurate project reporting is in place
  • Ensures that the project team delivers to meet the client expectations for quality and timeliness
  • Ensures that appropriate risk identification and issue-escalation procedures are in place
  • Ensures project specific training compliance of the project team
  • Ensures and/or manages project financials including provision of accurate revenue forecasts
  • Ensures that the project team understand and work to the scope of the contract
  • Identifies new opportunities through Change In Scope or add-on business from existing work
  • Ensures timely project close-out activities are completed

Consulting Activities and Relationship Management

  • Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
  • Delivers a limited range of consulting services within personal area of expertise under the guidance of the Project Lead and/or Technical SME
  • Completes assigned activities within project scope and objectives under the direction of the Project Lead and/or Technical SME
  • Identifies project and internal issues to senior colleagues and Project Lead and/or Technical SME
  • Interacts professionally at all working levels within a client organization and within Parexel
  • Identifies project and/or client needs to the Project Lead and/or
  • Technical SME
  • Interactions result in clients expressing satisfaction with service provided

Business Development

  • Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
  • Communicates potential new business lead to PC management and account managers

Parexel-related Activities

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

Skills:

  • Project management knowledge
  • Client-focused approach to work
  • Results orientation
  • Teamwork and collaboration skills
  • Consulting skills
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Critical thinking and problem-solving skills
  • Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:

  • Initial years of experience in an industry-related environment

Education:

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
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