Regulatory Affairs Consultant - Core Team

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

- Typically works within a team environment but may work independently delivering services within their technical area of expertise

- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts

- Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes

- Capitalizes on opportunities to improve one’s own performance and may provide suggestions for improving project efficiencies and results to the project technical lead

- Seeks out information from previous projects, other client work or from colleagues to complete assigned project activities

- Produces quality work that meets the expectations of project Team 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

- 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

- Provides technical and/or business consulting services within personal area of expertise

- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability

- Collaborates with colleagues and client to identify and resolve technical and process issues

- Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate methods of executing project activities

- Interacts professionally at multiple levels within a client organization and within Parexel

- Proactively assesses client needs and develops processes and solutions to address issues

- Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided

- Interactions result in clients expressing satisfaction with service provided

- May prepare and/ or deliver presentation with the support of senior colleagues

- May deliver training

- Mentor of junior staff

- Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope

Business Development

- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience

- Communicates potential new business leads to PC management and account managers

- May participate in project scoping call