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.
Knowledge in Regulatory Affairs Activities, focusing on CTAs (Phase I-IV) for various Therapeutic Areas
Proficient in Regulations, ideally with some knowledge in New Zealand
Preferred experience: Phase I or Early Phase studies, Studies involving Medical Devices, GMOs, Radiopharmaceuticals, Biological Drugs, Labelling for Investigational Medicinal Products
Experience in Quality Documentation and CMC (Composition, Manufacturing and Control of Investigational Medicinal Products) could be a plus.
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…