LEO Pharma

Technical Project Lead – medical device development

Can you bridge project management, design control and submissions?

If you have project management skills acquired from working with medical device development and you are looking for a job, where you can unfold everything you know and have major impact, this is your chance. At LEO Pharma you will join a small and agile team in the beginning of the company’s highly prioritised journey within device development. You will especially focus on coordination of project activities and you will get the opportunity to influence the way we run projects for the years to come – in a positive environment characterised by pioneering spirit, trust and collaboration.

 

Project management, risk management and submissions

As Technical Project Lead you will spend most of your time managing technical development activities. You will create project plans of your own as well as reviewing plans in order to evaluate coherence and realism. As part of this you will use your design control experience to assess risks. Additionally, you take ownership of submissions to authorities like FDA and EMA. You will:

  • Manage and coordinate project activities across several scientific disciplines 
  • Manage project deliveries – and coordinate with the overall responsible Project Manager 
  • Participate in development of project strategies  Manage and/or deliver input to submissions 
  • Ensure smooth and constructive collaboration with external partners – and control deliverables
  • Provide guidance to less experienced employees

Across all your tasks you will contribute to fulfil our mission of delivering user friendly and differentiated injection solutions based on thorough user and stakeholder understanding.

 

Experience across project management, design control and submissions

You have a degree at minimum Master’s level in Engineering or related backed by several years’ experience from a role that comprises technical project management and submissions. As part of this you have design control experience and understanding of risk management & systems engineering. With your technical understanding and project experience you can identify and solve complex challenges in close cooperation with both internal and external stakeholders.

Since you will work with a new business area you must thrive in an environment without a full set of processes, manuals and SOP’s. This requires overview and the confidence to make decisions and define the road ahead – in a complex organisational setting with many parallel agendas. Equally important is it that you can build relations and nurture constructive collaboration with multiple colleagues and external partners. Additionally, you have the good communication skills needed to get your messages across in written and spoken English.

 

Injection devices – your new team

You will join 7 skilled and highly motivated colleagues in Injection Devices based at LEO Pharma’s HQ in Ballerup. The department was established in February 2017 as part of LEO Pharma’s R&D organisation. Our responsibility covers product solutions across medical devices, drug-device combination products and device constituent parts from early ideation until transfer to commercial manufacturers.

As external partners deliver product development our role is to set the direction, oversee project progress and take ownership of submissions. The ambition is to grow as LEO Pharma is developing and expanding the presence in the injectable biologics area. We also support the long marketed Innohep® product against thrombosis.

We work as a team and share a passion for breaking new land in an environment characterised by helpfulness, knowledge sharing and collaboration.

We look forward to receiving your application.

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Working days:

Day

Application deadline:

05/08/2018

Location:

Ballerup, Copenhagen

Contacts:

Niels Gudiksen

Telephone: +45 31676830

Company homepage:

http://www.leopharma.com

Office address: