Regulatory Submission Co-ordinator - Devices

Employer
Location
Cambridge
Salary
£25 - 30 per hour
Posted
Sep 02, 2016
Closes
Sep 30, 2016
Ref
9021
Contact
Peter Duvall
Result Type
Jobs
Position Type
Contract
Hours
Full Time

A Regulatory Submission Co-ordinator role exists within the Device Centre of Excellence group (known as DCoE) based in Cambridge UK. DCoE is Pfizer's global drug delivery device team who engage in projects across all business units and therapy areas within Pfizer's global network. A core activity within device development is the co-ordination of data/information related to drug combination product device design and authorship of related product regulatory submission documentation.

The requirement is for a full time, office-based regulatory submission technical writer/co-ordinator and the role based in Cambridge UK. The specific requirements for the role are as follows:

Core Role Requirements:

  • Excellent written English skills
  • Strong technical writing skills
  • Strong ability to develop concise prose suitable for worldwide healthcare regulatory authorities
  • Comfortable working with all levels of the organisation
  • Strong attention to detail in graphical, typographical and copy
  • General requirements
  • Ability to work with multiple projects
  • Ability to understand medical device technical language
  • Capability to adhere to strict deadlines and prioritise work load under pressure
  • Ability to work on own and use initiative where required, or as part of a team

Skills and Experience:

  • Experience with authoring regulatory submission documentation such as electronic common technical document (eCTD) in healthcare, ideally for combination products with devices
  • Good project/time management skills
  • Good organization skills
  • Good IT skills essential - PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint
  • Minimum three years relevant experience. Five years of experience is preferred

Desirable but not essential skills /experience:

  • Pharmaceutical/Medical Device regulatory submission documentation authorship experience with US FDA
  • Appreciation for pharmaceutical/medical device regulatory requirements
  • Background in a medical field

If you are interested in this role, click the apply button. Please write a short note explaining why you are interested in this role and how you are suitable. If you have any difficulty applying, please contact Peter Duvan on 0203 0789 542. A full job description is available on request.