Regulatory Documentation Scientist

  • Salary: Competitive
  • REF Number: 00030684
  • Consultant: Oliver Care
  • Contact: 01438 743047
  • Date Published: 20.08.2014
  • Closed Date: 24.08.2015
  • Sector:
  • Location: Hertfordshire,
  • Discipline:

Oliver Care is recruiting for a Regulatory Documentation Scientist to join a company in the pharmaceutical industry at their site based in Hertfordshire on a permanent basis.

The main purpose of the role will be to;

  • Be responsible for the project management and preparation of vital safety regulatory reports for innovative products and be part of a global team driving the development of a rich pipeline of new products.
  • Manage the preparation of Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs) and Risk Management Plans (RMPs) ensuring that they are of highest possible quality and in line with relevant guidelines/requirements.
  • Work closely with the Safety Science Leader to ensure that any drug safety issues are effectively communicated in documents that you prepare and work with other departments to gather the safety and other content of your documents.

Further responsibilities will include:

  • Contribute to best practices and continuous improvement within Regulatory Documentation.
  • Liaising with contributors, analysing and interpreting data, creating production timelines and managing the review and publication process.
  • Applying your project management skills to ensure that documents are delivered on time and in accordance with best practice.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Educated to degree level or higher (PhD, MSc) in a scientific/biomedical or related field with previous experience in medical writing including scientific or medical reports ideally within a pharmaceutical environment.
  • A good knowledge of medical terminology with the ability to interpret data from a variety of sources, an accurate, clear and scientific style of written English and competent in the compilation of safety documents.
  • Strong communication skills with the ability to work as part of a team and with wider partners as well as a wide knowledge of the guidelines around Safety Reports and an organised and efficient approach.

This is an excellent opportunity to join a company at the forefront of ground-breaking new medicines, consistently pushing the boundaries of conventional thinking and embracing innovation and benefits include an annual bonus.

For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email ocare@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30684 in all correspondence.

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