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Amber Jobs Home > Jobs > South East / Health Care > Senior Regulatory Writer, Kent


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 Job Details:

Title:

Senior Regulatory Writer

Location:

Kent

Salary:

GBP 35,000 to GBP 40,000 per year (GBP 35 - 40K + Car + Benefits)

Description:

A Medical Writer is sought to carry out regulatory and drug safety medical writing activities to the highest possiblestandards for pharmaceutical companies.The Person:This is a position for a very experienced (at least 4 years in a pharmaceutical and/or CRO environment) and competentregulatory and/or drug safety medical writer who has in-depth knowledge, and exemplary writing and quality controlexperience, of a wide range of regulatory / drug safety documentation such as: Common Technical Documentation (includingModule 2:2.5, 2.7 and Module 5. Knowledge of non-clinical documentation would also be an advantage); Clinical StudyReports and protocols of all phases; investigator's brochures; US IND; and safety documentation including: periodicsafety reports, clinical expert statements, product labelling, and Annual Safety Reports.The position also requires experience of project managing large and complex projects, and training junior staff.The Company:This Medical Communication Agency supports the global pharmaceutical industry with a comprehensive medical writingservice delivering the full spectrum of regulatory, clinical and safety documentation.


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