Senior Associate - Regulatory Systems

Negotiable
  1. Permanent
  2. Officer /Associate
Hertfordshire
Posting date: 22 Aug 2019
RA.RE.24988_1566466897

A leading pharmaceutical client is searching for a Senior Associate - Regulatory Systems to join their team in the UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

Job Responsibilities:

  • Maintain the data integrity of data within the regulatory systems.
  • Ensure that Regulatory Information Systems are supported and managed according to business need and regulatory compliance.
  • Capture and implement system enhancements to optimise their operational capabilities according to business need.
  • Develop user requirements specifications for future information systems and create business justification for new systems.
  • Initiate UAT Scripts, deployment of software, design and deliver training for systems accordingly.
  • Stay current with industry best practice and software regards Regulatory Information Management, identifies opportunities to shorten approval timelines through enhanced knowledge sharing.
  • Engage with vendors and internal partners to drive future state of-the shelf software packages.
  • Ensure completeness of content contained in information management systems specifically as it relates to compliance.

Skills and Requirements:

  • College or University degree in an associated functional discipline (Chemistry or Pharmacy).
  • Experience with Systems, in relation to document management and publishing is required.
  • Knowledge of Regulatory and Submissions processes for EU, US, and possibly ROW, regions would be required.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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