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Regulatory Affairs Consultant (CMC Biologics)

Employer
Parexel
Location
Ireland
Salary
Competitive
Start date
29 Jul 2021
Closing date
21 Aug 2021

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

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 experienceQualifications

Minimum 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 languageWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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