Our client is a market leading management consultancy. Their Life Sciences Vertical focuses on providing services to support customers to run their existing business better and to develop their business model further to succeed in the drug development and clinical trials phases.

To support a client site in Germany, they need experience in Clinical Regulatory Affairs while having impecible communication skills. We are really looking for someone who can handle the projects, lead the teams and work at the site to run the client relationship.

This is based at their client site near Frankfurt.

Project Description

Set, build & stabilise a global regulatory team to centralise technical tasks associated with global Regulatory dossiers, including the steps of planning, publishing, submission, tracking, and archival.
Our client is looking for an Engagement Lead who will play a key role within a global project, focussing on the following.

Key Tasks

• First point of contact for the client to manage work delivered out of different locations
• In conjunction with Client, develops overall client strategy
• Manages multiple hubs (EU, US, APAC) and delivers outsourcing strategy
• Understands client expectations to engage and manage this across geographies
• Status reporting to client and other stakeholders
• Risk management, risk mitigation during operational phase
• Overall responsibility for meeting milestones and quality assurance
• In conjunction with client, ensures SOPs, work instructions, and best practice guides are followed during all aspects of the operational phase
• Focus on engagement experience and contract compliance
• Core responsibility to keep the team fully updated on all feedback coming from the client and ensuring that they adhere to client expectations
• Responsible for all billing and invoicing of the client as well as support the financial targets of the business by managing operational costs
• Onsite travel to client locations abroad if required.

Qualification and Experience

• Bachelor's or Master's degree in medicine / pharmacy / biomedical sciences or related OR Doctorate degree (PhD) in the above streams
• Profound knowledge and several years experience within Life Science industry is essential

Key Capabilities

• The ideal candidates should have Domain Expertise from Life Science/regulatory affairs
• Good Communication skills, persistent & patient, meticulous and detail oriented as well as resourceful and creative
• Strong analytical skills and good understanding of Quality and Agreed SLAs / KPIs in the Outsourcing Scenario.
• Understanding of appropriate technologies required to deliver the service
• Ability to define, schedule and execute formal customer review meetings
• Ability to understand the consulting business processes and problems

Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.

We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.

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