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Regulatory Affairs Consultant (CMC Biologics)

Parexel International Corporation

Dublin, Leinster, Ireland

A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides. A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, a Consultant assures the work of the entire team or work stream is delivered on time and that it meets client’s and PC’s quality expectations. • 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 o 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.) o Functions as the main client contact and ensures accurate project reporting is in place o Ensures that the project team delivers to meet the client expectations for quality and timeliness o Ensures that appropriate risk identification and issue-escalation procedures are in place o Ensures project specific training compliance of the project team o Ensures and/or manages project financials including provision of accurate revenue forecasts o Ensures that the project team understand and work to the scope of the contract o Identifies new opportunities through Change In Scope or add-on business from existing work o Ensures timely project close-out activities are completed • 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 • Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experienceQualificationsMinimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Several years of experience in an industry-related environment • Project management knowledge • Excellent interpersonal and intercultural communication skills, both written and verbal • Client-focused approach to work (Quality) • Results orientation • Teamwork and collaboration skills • Consulting skills • Critical thinking and problem-solving skills • Proficiency in local language and extensive working knowledge of the English language

Job posted: 2021-07-30

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