Regulatory Affairs Associate

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.

An Associate must have a knowledge of the organization’s 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 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