Location: Greater London/Surrey
Reference: PW 6717
Closing Date: 09 Dec 16
Salary (£): Competitive
Benefits: Comprehensive benefits package
Global organisation – top 20 pharma
High visibility within this role
Working with key internal stakeholders across Europe
Provides Secretariat and co-ordinates activities related to Investigator Sponsored Research Evaluation Committee and EMEA Project Review Committee) across all therapy areas for the Medical Affairs Group with the EMEA
The role supports provision of medical and scientific input by therapy Heads and other Medical Affairs team EMEA involved functions (including regulatory, quality, compliance, PV finance governance etc.)
Provides secretariat to the committees / regional approving bodies to ensure that all submissions, relating to ISRs and MA sponsored studies, adhere to the required company regional and global quality documents.
Support the Chair of the committees in assessing the potential impact on clinical practice, patient safety / benefit of the studies. Related to this, the position supports the (Sr) Director of Medical Science in representing Medical Affairs, EMEA and the affiliates at the global level and works closely with the functional head and colleagues from other parts of the organisation to provide input, help implement and enhance governance.
The role is also responsible for the management and maintenance of processes and quality documents related to Investigator Sponsored Research Evaluation and Project Review Committees that are aligned with global processes and gives training to those in Medical Affairs, EMEA involved in ISRs and submissions to the Project Review Committee
QUALIFICATIONS / EXPERIENCE REQUIRED:
· Significant experience in clinical studies management and monitoring
· Understanding and awareness of information sources related to clinical trials and relevant legislation
· Excellent project management and organisation skills
· Awareness of legal process related to ISRs and ability to cooperate in drafting legal contracts based on existing templates
· Used to working with high workloads and time pressures
· Strong presentation skills
· Excellent communication and networking skills
· Significant analytical skills
· Able to work independently, use initiative as part of a pan-European team in a multicultural environment
· Building trust and strong internal and external relationships
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW 6717
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
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