Project Manager / Business Lead with pharma / life sciences Regulatory Affairs experience

Passionate about project management and/or Agile delivery? Looking for an exciting challenge in a successful and growing company?

You are a leader with either of the following backgrounds:

• A senior business consultant with some project management or track lead experience or
• An Advanced or Senior Project Manager or
• A Release Train Engineer

We are looking for new colleagues to lead implementation of business solutions (often cloud applications) for our pharma / life science customers in collaboration with NNIT partners (e.g., Veeva), especially within the area of Regulatory Affairs.

Your responsibilities as a Project Manager

As our new Project Manager or Agile Lead, you will play a vital part both in relation to our customers and internally in NNIT. The role is very versatile and challenging with a large degree of responsibility and independence.

Your responsibilities will include:

• Contribute with project management expertise in the sales phase
• Initiate projects by identifying and mobilizing the project team
• Executing and managing project deliveries and resources according to the customer contract according to agreed methodology (e.g., agile)
• Manage project according to NNIT internal business case for customer contract
• Define and manage risks and issues
• Ensure a high level of customer satisfaction

You will join our project management team

You will become part of the NNIT Life Sciences Project Management team (currently physically distributed across units in Denmark, Czech Republic, Switzerland). There is a great diversity in the department both in terms of gender, age, experience, domain knowledge and nationality. We also have colleagues delivering from European countries not having an NNIT office. We encourage all Project Managers to knowledge share within the project manager community.

Your Business understanding and Regulatory Affairs Project Experience

We are looking for people with some knowledge or experience from Regulatory Affairs Project. With process and/or related IT systems experience for

• • Registrations / Submissions
    • Investigational submissions (IND, CTA, other)
    • Marketed submissions (IMA, NDA)
    • Variations, amendments, or new indications
    
    
  • Publishing and Archiving
  
  

Your PM qualifications and experience

• A relevant master’s degree
• 5+ years of project management (possibly with PMP/Prince2 certification) or business consultant lead experience within business or IT Implementation projects
• Experience with delivering to pharma and/or life science customers, preferably delivering according to GxP requirements.
• Agile (SAFe/scrum) experience and/or certification (as Scrum Master, Release Train Engineer, Product Owner, or simply Agile lead)

And possibly also:

• Experience with IT Software Development Lifecycle (SDLC) (via agile or waterfall)

The Business Transformation and Implementation projects we are involved in most often contain several of the following elements:

• • Process workshops defining to-be Processes via Use cases / User stories
  • Facilitating and provide content for configuration workshops (configuration often done by cloud vendor) based on the Use cases / User stories
  • Data Migration
  • Interface/Integration development (SAP PO, MuleSoft, Del Boomi)
  • Validation
  • OCM/Training
  
  

You may be a more business-oriented Project Manager with experience in implementation requirements and business processes into a new solution managing different stakeholder groups within the R&D Business Process areas. Or you may be a more technical/IT oriented Project Manager with experience in implementing interfaces and migrating data/content to a new system landscape. We are looking to hire both profiles.

Through your conduct and drive you will contribute to motivate and develop the project participants. You are customer focused with a passion for understanding the customer's value chain to deliver to customer satisfaction. You relate well to people and you work independently with a large personal drive while also securing project results through personal leadership.

You are fluent in English, written and oral.

Travel activities (with due respect for COVID-19) must be expected as we have pharma and life sciences customers throughout Europe.