Consulting Opportunities at Parexel
Consulting jobs at Parexel help our client companies get and keep biopharmaceutical and medical devices on the market. Through integrated product development services, you’ll help clients maximize their product portfolio value and protect them from regulatory risk. Are you experienced in Early Stage Development, Clinical Trial Regulatory Services, Late Stage Development and Strategic GxP Compliance? Explore Consulting jobs at Parexel.
Senior Consultant / Regulatory Affairs Project LeaderJob ID post-40024818 USA - Any Region - Home Based
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.
QualificationsSuccessful 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
EEO DisclaimerParexel 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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