Job Posted: 22 Feb 2017

Regulatory Officer / Scientific Writer

35k - 50k pa + bonus and benefits| Paris| Permanent

An excellent opportunity has arisen for an experienced Regulatory Affairs professional / Regulatory Writer to join a leading Pharmaceutical company based in Paris.

Responsibilities:
* Plan the clinical development program
* Allocate appropriate resources for clinical studies
* Oversee the smooth conduct of clinical trials and publications
* Assist in the preparation and validation of clinical trial protocols
* Manage, train and supervise the team of Clinical Research Attaché based in France and the US
* Monitor the quality system (SOP) (write, update, validate) and train relevant staff
* Check the SOP in accordance with the requirements of society and the applicable regulatory requirements (ICH-GCP, the European Union directives, CFR)
* Follow the specifications in clinical monitoring provider companies

Experience Required:
* PharmD graduate with ideally MD or PhD
* Significant experience minimum 7 years in clinical research in a similar position
* Thorough knowledge of clinical development of regulations (EMA, FDA)
* CTA Experience for submissions with the EMA, FDA and national competent authorities
* Excellent verbal and written communication
* Excellent organizational and managerial skills
* Excellent computer skills and electronic applications
* essential fluent English

For further details about this role or other vacancies within Regulatory Affairs please contact Tim Barratt on [Phone number removed] or send a copy of your CV to [Email address removed]

Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years. Clients come to us for three main reasons:

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We think it's because we're a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.