Global Clinical Trial Submissions Manager

Recruiter
Regulatory Professionals
Location
London (Greater)
Posted
31 Jan 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Global Clinical Trial Submissions Manager Kent or Surrey 6 month contract Up to £45 per hour (DOE) Job Ref: J32122 Our client; a world renowned leader within the pharmaceutical industry seeks an experienced GSM to join their established team on a 6 month contract basis. As a Global CTA Submission Manager you will be responsible for leading operational submissions executions for designated CTA"e;s. Driving the submissions team towards the delivery of globally compliant submission ready components. Job Responsibilities include; - Drive global submission management activities and partnering with product teams/ third party partners - Ensure high quality components and submissions are compliant with industry guidelines and regulatory strategies - Prepare, review and submit submissions to regional CTA hub - Coordinate submission production. Candidate Requirements include; - Life Science degree or equivalent - In depth understanding and proven execution of CTA process globally - Comprehensive understanding of ICH/GCP and EU Clinical Trial Directive - Strong knowledge base of the drug development process, regulatory affairs, clinical trial applications and submission management. Regulatory, Regulatory Affairs, Submission, CTA, clinical trial application, submission manager, GSM, CTA-SM, pharma, life sciences, Kent, Essex, Hertfordshire, Buckinghamshire, Surrey, Berkshire, Hampshire, London, Middlesex. -1

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