Project Manager Regulatory and Quality

仕事内容

In order to continue supporting our clients with their future challenges, we are always looking for colleagues to join our Modis Life Sciences team. Are you looking for a next challenging step in your career? And do you want to be part of an international company that brings together the best experts in Life Sciences, IT and Engineering? Then be sure to read on!

At Modis Life Sciences, we prioritise your professional development. By putting your talents and ambitions first, we can offer you projects that inspire, challenge and reward you – all in line with your unique profile. It’s a win-win. Your working environment matters to us. Thanks to our broad network, we can connect you with diverse internal and external careers and projects in Life Sciences. You have options – only settle for the best.

As a project manager working for Modis you help our customers to better deliver their projects. You listen to their needs, give advice, and support them with tools to optimize their project management approach.

At the customer, you take on the role of Project Manager, Regulatory & Quality. In this role, you supportRegulatory & Quality leaders with initiatives that aim to create a future proof regulatory framework as part of the Pharmaceutical strategy for Europe.

In general, the project manager Regulatory Affairs will have the following core responsibilities:

• Translatescientific strategy into comprehensive cross-functional project plans that are aligned with the broader organizational objectives.
• Manageone or more regulatory projects within approved budgets and timelines.
• You collaboratewith internal regulatory departments and company leadership.
• You integrateconsulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical, and business).
• Define the budget and resource needs, create the work breakdown structure, set deliverables, perform critical path analysis, compose the project team.
• Monitor and optimizeproject planning, control resources, scope, and budget.
• Manage the functional project team and take full accountability of project delivery, balancing quality, scope, and timelines.
• Conduct contingency planning, perform scenario analysis, identify, and manage operational risks and issues.
• Ensure effective and efficient project communication, report the project status to, and manage stakeholders.
• Provide regular updates regarding the status and progress of projects.
• Participate in continuous improvement initiatives.

Requirements:

• Master’s degree in life sciencessuch as pharmacy, biology, bio engineering or biomedical sciences (PhD is an asset).
• Previous experience in the pharmaceutical, biotechnology, medical technology, or healthcare sector is a plus.
• Good knowledge of the drug development cycle, and regulatory requirements is a plus.
• Strong organizational skillsto cope with multi-tasking which result in a goal-oriented approach without losing the attention to details.
• Project management certification (PMP® or equivalent) is a plus.
• Excellent communication skills in setting clear objectives, persuading others to accept new approaches and gaining alignment on divergent issues.
• Good coaching, collaboration, and leadership skills.
• Good knowledge of project management methodology (waterfall, scrum) and project planning tools (MS Project, Planisware ...) is a plus.
• Able to work in an international environment and as part of virtual project teams.
• Perfectly English speaking (Dutch is a plus).
• Literacy in MS Office suite.
• Work days mix between Temse office and homework

Why work as a consultant for Modis Life Sciences?

You will receive a permanent contract. At Modis Life Sciences you’re not just a consultant, you are one of a kind. Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.

Interested? Don’t hesitate to contact us!

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