Outsourcing Manager and Chair of Comparator Competency Team - Denmark
- Are you looking for an opportunity to apply your project management and negotiation skills to exciting challenges and play a key role in supporting an ambitious drug development pipeline in Chemistry, Manufacturing and Control (CMC) Development?
- Our company is successfully expanding its drug development pipeline to benefit more than 20 million patients world-wide.
- This growing pipeline increases the number of clinical trials conducted and hence the need for effectively managing and handling the supply of comparators to our many clinical trials worldwide. Perhaps you could be our new Outsourcing Manager and Comparator Competency Team Chair, responsible for ensuring smooth and effective management of comparators and comparator suppliers.
About the department
- CMC Sourcing Support department is responsible for all sourcing and outsourcing activities which support the company development pipeline.
- Comprising 11 dedicated and experienced employees, the department is responsible for executing sourcing and outsourcing activities, from selecting a competent collaboration partner, negotiating the contractual framework, to project management of the outsourcing project until all deliverables are completed.
- The department is a part of CMC Development in R&D and plays a significant role in bringing new medicinal products to the market.
- As Comparator Competency Team Chair, your primary responsibility is to chair a cross-organisational group, the Comparator Competency Team (CCT), which comprises diverse stakeholders from Clinical Supplies, Drug Product development, Comparator Sourcing and Regulatory Affairs.
- As Chair, you are responsible for managing and driving the activities of the group and securing guidance and approval from the CCT Steering Group. The CCT ensures the establishment of processes and strategies for smooth and timely operations when handling comparators for use in clinical trials.
- Some of your responsibilities are to ensure the mapping, improvement, alignment and communication of comparator handling processes across functional areas.
- You create these standards, processes and strategies and ensure these are anchored in relevant Standard Operating Procedures (SOPs) and communicated across projects and trials.
- You ensure that regulatory requirements for comparators used in clinical trials is consolidated and transformed into relevant standards.
- As Outsourcing Manager for comparators, you secure the sourcing of external comparators and other products for clinical trials.
- You develop and follow relevant processes and SOPs within comparator and clinical trial supply sourcing.
- You will be responsible for establishing and maintaining agreements with comparator suppliers.
- This position offers you exciting challenges as well as broad organisational exposure.
- You will experience a high degree of responsibility in an engaging and professional environment.
- You hold an Bachelor’s or Master’s degree in Science or Business (e.g. Supply Chain) and have at least 5 year experience in the Pharmaceutical industry.
- You have experience in Project Management with a high level of execution.
- Prior experience working with outsourcing or sourcing of supplies for clinical trials, in particular sourcing of comparators is an asset.
- Furthermore, you have a solid understanding of clinical development and CMC activities.
- You have excellent contract negotiation skills.
- You possess excellent stakeholder management and communication skills, and can work in a complex inter-disciplinary organisation while influencing and maintaining focus.
- You are comfortable and competent in dealing with a diverse set of internal and external stakeholders at all organisational levels.
- You must be fluent in oral and written English.
- As a person you are proactive, positive, and independent, and you are able to handle many tasks at the same time.
- You enjoy working as part of a team, and you are able to use your own experiences and personal drive to make the best of the team you are in.
- You thrive in a changeable environment where prioritization of complex tasks is required on a regular basis.
- You constantly strive for improvement and pay close attention to details while keeping sight of the broader perspective.
- We use our skills, dedication and ambition to help people with diabetes.
- We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.