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Regulatory Affairs Associate @ Parexel

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 Regulatory Affairs Associate

Job Description


An Associate must have a knowledge of the organizations basic consulting models and methodologies as well as basic knowledge of what services PC provides. An Associate must be technically competent and continually developing the skills as defined in the key accountabilities section of this document. An Associate, under the general direction of a Project Lead and/or Technical SME, takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of PC and the client. The guidance of more senior staff may be needed to accomplish more complex tasks. An Associate may act in a client facing role with clear guidance and support from line management.
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 ones 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 organizations 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.Qualifications
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 Bachelors Degree in a Scientific or Technical Discipline

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Pharmaceutical
Role Category: Other Roles
Role/Responsibilies: Regulatory Affairs Associate

Contact Details:

Company: Parexel International
Location(s): Selangor , Malaysia

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Parexel

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will...