Clinical Research Managers / Regulatory Affairs Managers

Poolia Science

Presentation
For our clients in the pharmaceutical and medical technology industry, we are looking for Study Managers for clinical trials and Regulatory Affairs Managers.

Preferred staring date is during the spring and the positions are temporary or permanent. Selections and interviews are held on an ongoing basis so please apply today!

Arbetsuppgifter
As a study manager for clinical trials you will manage a portfolio of global clinical studies across all phases within a drug development programme. You will be working with:

- Lead and provide direction to Study Drug Groups
- Ensure the team delivers clinical supplies effectively
- Balancing cost and risk
- Supply with expert input and support from cross functional groups
- Understand and translate clinical study protocol requirements into demand
- Author the drug supply section of Clinical Study Protocol and lead development of master label text
- Use simulation tools and supply chain expertise to design optimised, lean supply chains for individual studies
- Ensure delivery of the end to end supply of materials to meet study needs
- Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract
- Review changes to the contract with CRO partners and Sourcing Managers as necessary
- Monitor the budget for individual study supply activities and materials for the project
- Manage change in demand and supply and resolve issues
- Handle Regulatory affair issues

Utbildning/erfarenhet
You have a a suitable degree, qualification or experience in a drug development discipline or similar. You have experience in managing and influencing customer demands, a deep knowledge of the clinical trial directive and global regulatory environment impacting the provision of investigational products and preferrably supply chain experience. Additionally you have knowledge of drug development processes and clinical development processes relevant to clinical materials.

Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries are other important skills as well as experience of project management and risk identification are preferred. You have excellent written and verbal communication skills.

Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning
Poolia Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right of this advertisement. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail adress is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.