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Senior Project Specialist - Regulatory Affairs

Parexel International Corporation

USA - Any Region - Home Based

Join Parexel’s best-in-class Regulatory Consulting Team as a home-based Senior Project Specialist and use your Regulatory Affairs knowledge and project management skills to ensure successful engagements with a variety of clients and ensure they receive quality, on time deliverables!

As a Senior Project Specialist, you will demonstrate your role’s impact on project profitability, quality, and timeliness by utilizing your expertise in project integration and act accordingly. You will maintain an overview of the project, contributing to milestone achievement, while developing higher level project management skills.

Key Accountabilities Include:

Project Initiation Management - Ensures tools are set-up according to SOPs and work instructions, e.g. Project Management Plan, SOPs list, TIME codes list, team list, project specific training management in LMS. Cooperates with the PFA to ensure that any systems and system interfaces are functioning and are ready for use by the project teams. Work with PL/TL to provide initial resource plan to SRO.

Project Execution and Control Management - Responsible for project reporting and analysis and for highlighting issues for project team. Ensures system data or compliance issues are followed up and solved as needed. Maintains Project Schedule.

Project Integration Management - Responsible for drafting a consistent coherent project management plan, including coordinated planning of the different project activities and input from the different functions. The plan covers all parts of the project to be integrated together (scope, CIS, risk plan, quality plan, communication plan, schedule, and resource plan). Responsible for updating the project plan as needed and collaborating with the PL/TL to execute the plan and close the project. Use systems and tools expertise in collaboration with project team to identify, unify, and coordinate the various project management activities within the various processes. Collaborates with PL/TL to make choices about where to concentrate resources and effort on any given day, anticipating potential issues, dealing with these issues before they become critical, and coordinating work of the overall project good. The integration effort also involves making trade-offs among competing objectives and alternatives.

Project Meeting Management - Support preparation of required information for project review meeting; reporting of owned responsibilities during meeting attendance; support tracking and follow-up of action items.

Project Financial Management - Reviewing and processing pass through cost invoicing, marking any inconsistencies and wrong bookings for PL/TL review

Project Closure Management - Ensures all systems are up to date with final information and all issues are closed. Collaborates with PL/TL in ensuring that documents archived, and final work handed over to the client. Closes all project systems, including financial and document archiving, upon project end QualificationsSkills:

•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

•Previous experience with financial tracking and project management tools is preferred

•Willingness to work in a matrix environment and to value the importance of teamwork

Knowledge and Experience:

•3-5 years previous experience in the Life Science/Pharmaceutical industry working directly for either a Pharma or Biotech company or a contract research organization. Consideration will also be given to strong candidates with past experience in a healthcare related organization or consultancy firm

•1-2 years previous experience working in a project management related role

Education:

•Bachelor’s degree in a science-related field, with an advanced degree desirable

•PMP or equivalent desirable

Other:

•The flexibility to travel @20% domestically and internationally may be required in the future

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccinationEEO 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.

Job posted: 2022-05-28

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