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.

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