PRA Health Sciences

Associate Regulatory Publisher - London, UK

Aldwych, London
20 Dec 2018
22 Feb 2019
FC 2018 48057

Position overview:

With oversight from more senior members of the Global Publishing team the Associate Regulatory Publishing Specialist will contribute to the Compilation and Publishing of all global regulatory submission types and submission support activities in accordance with client objectives.

The work in this department is varied and fast-paced. Key accountabilities will include:

  • Assist in ensuring submissions of low complexity are published according to standard operating procedures (SOPs) within established timeframes.
  • Perform Quality Control Review of submissions and documents to client and regulatory agency specifications
  • Support report or document level publishing as required
  • Proactively identify and escalates publishing issues as necessary.
  • Actively participates in local and global publishing meetings to ensure publishing processes are consistent among regions.
  • Helps perform quality control review of published and printed documents to client and regulatory agency specifications prior to client delivery.

With support from more experienced Publishing colleagues, including your manager, you will work in a close team across a broad portfolio of established products. As your experience grows, you can expect to work on more complex submissions including MAAs, and grow your career within regulatory publishing or even within another area of regulatory affairs.

You are:

Quick to learn, friendly and detailed-oriented.

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • An undergraduate degree, ideally in a life sciences discipline
  • Ideally we are seeking candidates with some previous experience within the pharmaceutical industry. For candidates without previous experience, we expect to see an awareness and genuine interest in regulatory affairs and drug development.
  • Strong IT skills, and an ability to learn new systems quickly and confidently
  • A willingness to learn from others

Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

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