Senior Associate - Regulatory Publishing

31 Mar 2021
30 Apr 2021
Ben Traies
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management
As a Senior Associate Publisher, you will be providing primary support for the creation and maintenance of pharmaceutical product related reports such as IMPDs, Protocols, Nonclinical and Clinical Study reports and SEND related activities. In addition to collaborating with Report Publishing team members, you will be expected to collaborate with GSM submission managers to ensure the timely delivery of studies required for Global Submissions. You will also be expected to ensure the quality and formatting of each report according to established internal guidelines.

What are we looking for?
You will have:
  • College or University degree preferred and/not mandatory
  • Demonstrated experience in Regulatory Affairs publishing
  • Excellent knowledge of written and spoken English
  • Good knowledge (or capability) of electronic Publishing related software programs
  • Demonstrated experience with Systems, in relation to Document Management
  • Previous experience in pharmaceutical industry an advantage
  • Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build consensus.
  • Experience in handling multiple tasks
  • Knowledge of MS Office (Word, Excel, PowerPoint, Project), Adobe acrobat as well as being familiar with the use of multiple regulatory system applications
  • Understanding of ICH guidelines and eCTD submissions
  • High attention to detail,
  • strong organisational/self-management skills when required to work independently
  • Self-motivated and proactive
  • Strong customer focus
  • Strategic thinker
Quote reference 50301 in all correspondence

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