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Senior Consultant / Regulatory Affairs Project Leader
PAREXEL International Corporation
Own the challenges that lead to innovation and growth
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
Promoted to VP Clinical Operations, and relocated to the US in 2017.
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
Advanced into Senior Manager, Human Resources
Promoted to Manager, Human Resources Operations
Joined Parexel as a Human Resources Operations Partner.
Human Resources Business Partner at leading pharmaceutical company.
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
Promoted to Associate Director of IT Program and Project Management at Parexel.
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
Promoted to Project Manager for clinical oncology trials.
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
Corporate Vice President, General Manager – Japan
Vice President, Growth Accounts
Senior Director of Business Development at Parexel.
Associate in the Proposal Development department at Parexel.
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
Promoted to Senior Director of Clinical Application Development and Technology.
Promoted to Associate Director of IT.
Promoted to Senior Programmer.
Joined Parexel in Clinical IT.
Received Master's in Computer Applications.
Own the challenges, program your future
Promoted to Senior Manager, Statistical Programming, with increasing responsibilities for department development and team supervision.
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior Director
Deborah – Senior Manager
Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development
Pawel – Senior Manager
Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Consultant / Regulatory Affairs Project Leader
Parexel currently has an excellent opportunity for a Regulatory Project Leader/Senior Consultant with previous experience in Regulatory Affairs and past experience managing quality, on-time regulatory applications and filings. This Regionally Home Based position is part of our growing Regulatory Consulting Services Team and offers an amazing opportunity to join an industry leader in a field that continues to see tremendous growth and opportunity!
As a Regulatory Project Leader you will provide leadership to project teams and manage the day to day operations of domestic and international Regulatory projects. You will strive to achieve operational excellence through on time delivery that is within budget and to the highest quality with the goal to exceed client expectations.
Successful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at least 10 years' experience working as a Regulatory Project Leader/Manager within a CRO (preferred), a Global Health Authority ie. the FDA, a Biotech or a Pharmaceutical Company. Past experience overseeing a cross-functional team to create preINDs, INDs, NDAs, and/or BLAs is required.
This position also requires experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience in Regulatory Affairs related activities.
Successful candidates must also possess the following:
•The ability to build and sustain relationships
•Critical thinking and problem solving
•The ability to influence and lead teams
•Financial management skills
•Strategic thinking skills
•Attention to detail and commitment to quality
•Conflict management skills
•Contingency planning and risk management skills
•People management skills
•Excellent interpersonal, verbal and written communication skills
•Client focused approach to work
•A flexible attitude with respect to work assignments and new learning
•Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
•Proficient in local language where appropriate and profound working knowledge of the English language
•Proficient in Microsoft Excel, Power Point, MS Project and Word.
•Experience with Parexel systems is a plus
•Willingness to work in a matrix environment and to value the importance of teamwork.
•Experience with financials and managing project budgets
Up to approximately 30% Domestic and/or International Travel may be required
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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