Clinical trials set-up & planning professional for Clinical Supplies

• Clinical Development & Medical
• Måløv

Are you passionate about bringing new drugs to market? Do you enjoy coordinating multiple activities, with focus on structure, simplicity and deadlines? Then you might be our next Trial Set-up planner.

About the department

Clinical Supplies (CS) in Chemistry Manufacturing & Control (CMC) Development is part of Novo Nordisk Research and Development (R&D) and plays a key role in bringing new drugs to market by planning, labelling, packaging and distribution of products for Novo Nordisk clinical trials worldwide. Our department, Clinical Supplies Trial Set-up (CSTS) is organised in three teams. You will be part of the team Project & Trial Set-Up, a dedicated and experienced team of 17 highly skilled and professional employees. We support the global clinical supply chain by planning the execution of clinical trials and translating trial protocol & scientific documents into trial master data and labels for Clinical Trials.

The position

The team establishes Trial Master Data for the Clinical Supplies chain. The goal to ensure smooth handling of trials through planning trial execution as well as reviewing clinical protocols, product specifications, local regulatory label requirements and ensuring correct information on the clinical product labels. You are a key member of the clinical trial study team prior to initiation of a clinical protocol and must utilize your understanding of R&D to consolidate and transform knowledge and needs into relevant supply chain standards. You support processes throughout Clinical Supplies by facilitating actions and adapting to changes in clinical trial designs and plans.

All our processes work across a wide range of departments and areas (Global Development, Device R&D, Regulatory Affairs and other departments in CS). You will therefore be coordinating, managing stakeholders and making sure that all trials run as planned and we deliver on deadlines and quality, as promised.

Qualifications

You have a Master degree (MSc.) within production, pharmaceutical science or similar. Ideally, you have some experience in this field from working with clinical trials or within pharmaceutical production, regulatory affairs, or similar areas. You speak and write Danish fluently and English at a professional level. Good understanding of LEAN, GMP and the pharma industry is considered an advantage.

You are independent, self-driven and ambitious as you will be required to make decisions every day. You are a dedicated team player who inspires trust amongst your colleagues and stakeholders. You see continuous improvement as a natural part of your job.

Contact

For further information, please contact Mette Ellemann-Søtofte +45 3079 4161.

Deadline

16th of October 2019

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.