Senior Project Manager - Regulatory Compliance

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Purpose:

The Senior Regulatory Project Manager leads APAC and ex-APAC compliance projects as part of Parexel's Strategic Compliance Consulting Global Operation team. Acting as a Project Lead (PL), this role collaborates with Parexel Project Technical Leads (TL) and Subject Matter Experts to manage project timelines, resources, and stakeholder alignment while ensuring adherence to Parexel's quality standards, effective budget management, fiscal responsibility, and timely project delivery. This highly visible, cross-functional role requires strong project leadership, agility, and strategic foresight to support the mission of bringing quality drug products to patients worldwide.

General areas of responsibility include: client liaison and relationship management, project assessment and initiation, resource planning and identification, project implementation scheduling, leading and motivating cross-functional teams, milestone planning and forecasting, ensuring projects progress according to contract and quality standards, producing key project progress reports, managing communication and financial oversight between the Parexel project team and clients, aligning cross-functional stakeholders to manage complex timelines, anticipating challenges, and enabling successful delivery of project milestones.

Key Accountabilities:

Project Initiation Management

•Ensure tools are set-up according to SOP’s and work instructions, e.g., Project management Plan, SOP’s list, Workday Codes list, team list, project specific trainings management in LMS.

•Cooperate with the Finance Business Partner (FBP) to ensure that any systems and system interfaces are functioning and are ready for use by the project teams.

•Work as PL with TL to provide initial schedule and resource plan to Compliance senior management team.

•May also own the client relationship and responsibility for client communication ensuring high client satisfaction.

•Proactive approach to providing solution set for clients.

Project Execution Management

•Schedule client kick-off-meeting and discussions with client, by establishing client expectations for project delivery, communication, and client specific metrics. Ensure the scope of the project is well understood by the project team and set the team expectations.

•Review the project contract exhibit and ensure relevant team members have received budgeted hours.

•Manage the Onboarding Guideline of the project team, oversee request for resources, review proposed team members for suitability and manage any project team changes throughout the duration of the project.

•Work with the Project Specialist (PS), on developing a project plan and tools including all elements listed in the project plan template as appropriate for the project (Roles and Responsibilities, WBS, Project Plan, Communication Plan, Risk Analysis, etc).

•Review initial budget request to FBP/CS for any project specific adaptations.

•Review and finalize project metrics with FBP and TL/PS.

•Participate in or manage the team kick-off meeting, ensure the scope of the project is well understood by the project team and that the appropriate resourcing has been assigned.

•Work with the TL to set up project-related training as needed for team members.

•Schedule the Lessons Learned / Opportunities meeting with Consulting Lead to ensure client’s needs are well met.

Project Implementation, Control & Evaluation

•Schedule client kick-off-meeting and discussions with client, by establishing client expectations for project delivery, communication, and client specific metrics. Ensure the scope of the project is well understood by the project team and set the team expectations.

•Review the project contract exhibit and ensure relevant team members have received budgeted hours.

•Manage the Onboarding Guideline of the project team, oversee request for resources, review proposed team members for suitability and manage any project team changes throughout the duration of the project.

•Work with the Project Specialist (PS), on developing a project plan and tools including all elements listed in the project plan template as appropriate for the project (Roles and Responsibilities, WBS, Project Plan, Communication Plan, Risk Analysis, etc).

•Review initial budget request to FBP/CS for any project specific adaptations.

•Review and finalize project metrics with FBP and TL/PS.

•Participate in or manage the team kick-off meeting, ensure the scope of the project is well understood by the project team and that the appropriate resourcing has been assigned.

•Work with the TL to set up project-related training as needed for team members.

•Schedule the Lessons Learned / Opportunities meeting with Consulting Lead to ensure client’s needs are well met.

•Manage the project proactively, anticipating problems and providing resolutions in a timely manner.

•Proactively communicate with the TL and Consulting Lead or directly with the client ensuring the client has all the information required on project progress and status (risk analyses, contingency plans, technical information, significant changes of any kind etc.); provide pro-active decisions /solutions and how the project objectives are being, or should be, achieved.

Communication

•Proactively identify and communicate project team and client team roles and responsibilities to client and their affiliates, as appropriate.

•Conduct or participate in project team meetings on a regular basis to ensure project objectives are met; ensure the on-going communication to team members of the scope of work, timeline and project goals, technical information, and input from client throughout the project including significant changes in resourcing, scope of work and timelines.

•Conduct or participate in regular meetings/calls with client to ensure they are fully informed of project progress, pro-active decisions / solutions and how the project objectives are being achieved.

•Communicate to Line Managers or Senior Management any needs or concerns regarding level of training or performance of any team member.

•Provide Line Managers with input regarding team members’ performance as needed for employees’ periodic performance review.

•Work with team to prepare and update project plans, project status and other administrative reports and submit to clients as required by the contract exhibit, and other internal stakeholders.

•Communicate fiscal, contractual, resource, deliverable and client related issues to management as appropriate.

Project Closure Management

•Working independently or with a Project Specialist, oversee all administrative closeout procedures are completed, according to Project Closeout Checklist.

•Ensure project is archived and all documentation returned to the client as specified the by the contract.

•Conduct or participate in end of project meeting to ensure lessons learned information is documented and passed on via appropriate channels.