Associate Project Coordinator for R&D – Research & Development - Denmark
Want to know company name or location? Company managed [?]
Posted on : 08 March 2017
- Are you interested in clinical research, clinical supplies and project management?
- If yes, then please consider joining Clinical Supplies (CS) where we are responsible for the planning, production, packaging, labeling and distribution of products for our company trials worldwide. We make sure that the required trial medication is provided to the patients participating in all our clinical trials.
About the department
- We are 45 dedicated people in the department Clinical Supplies Project Planning, where you will be part of the Project Entry team.
- We are responsible for integrating Chemistry, Manufacturing and Control (CMC) with the clinical pipeline by ensuring, designing, planning and establishing a robust clinical supply chain.
- The team consist of 11 highly skilled, professional, and very engaged employees.
- The department is a part of CMC Clinical Supplies in R&D and play a significant role in bringing new medicinal products to the marked.
- We operate in a cross-functional area where GMP meets GCP.
- We aim to always use CS standards or to improve existing solutions to the benefit of our stakeholders.
- You will be responsible for managing clinical trials (phase I-IV) and to drive and support the operations in the team across projects.
- We are a key stakeholder prior to initiation of a clinical protocol and must utilize the understanding of the various processes in R&D, to be able to consolidate and transform knowledge and needs into relevant standards in CS.
- This requires effectively communication and you will be the lead communicator across areas conveying decisions and standards in a professional and timely manner.
- You support processes across CS by facilitating actions and adapting to strategic changes in clinical trial design and mitigating CMC challenges.
- You will be part of a strong and independent team but simultaneously we are very reliant on each other’s professional competencies, discussions, and feedback on subject matters and daily challenges in a great and engaging team atmosphere. The position is a maternity cover and starts as soon as possible.
- You hold a relevant Master’s degree and preferably have some experience working with e.g. Clinical Supplies, Clinical Trial Management, and Regulatory Affairs or within CMC development in the pharmaceutical industry or equivalent.
- However, you might also be a newly graduate with relevant experience.
- Furthermore, you are highly dedicated with a quality mind-set and knowledge of GxP.
- It is an advantage to have acquaintance of LEAN activities to be able to drive and participate in improvement processes.
- As a person you thrive in a changeable environment where prioritization of tasks is required on a regular basis.
- Stakeholder management is of the utmost importance and hence, fluent English and Danish both spoken and written are prerequisite as well as excellent communication skills.
- You are dedicated, flexible and you are good at building and maintaining relations internally as well as externally gaining trust and demonstrating reliability.
- We expect you to be independent, efficient, self-driven, ambitious, good at multi-tasking, and a team player with a good sense of humor who likes challenges.
- You must be able to handle many stakeholders with different backgrounds.
- You should enjoy striving for perfection and working in a structured way.
Working with Us:
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary and talented people as well as to benefit from a wide range of possibilities for professional and personal development.