Strategic Regulatory Medical Writers

  • Salary: £450-500 per day
  • REF Number: 00046957
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 21.11.2019
  • Sector: Non-Specific
  • Location: East Anglia
  • Discipline: Regulatory Affairs, Medical Writing

CK Group is recruiting for a Strategic Regulatory Medical Writer to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 6 months and has a daily rate of £450-500.

The Company: Our client is a global pharmaceutical company with a large presence and multiple sites in the UK. They produce innovative medicines across a range of therapeutic areas to enhance the health and lives of their patients.

The Location: Located within the South East of England in Melbourn. Melbourn is a large village in the far south west of Cambridgeshire. It is located next to the A10 just north of Royston.

The Role: As a Senior Medical Communications Scientist (MCS), you will provide expert communications leadership drug projects and drive strategic medical writing, advocating communications excellence in your team. The MCS ensures that clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices.

Key Responsibilities:

  • Lead the authoring of clinical documents.
  • Writes clinical regulatory and other supporting documents/submissions for assigned studies/indications for one or more programs/molecules, and manages the overall development and approval process.
  • Critically analyses, synthesizes, and presents complex information from a broad range of scientific disciplines and therapeutic areas.
  • Provides critical review of documents from authors assigned to document deliverables for correctness, clarity, completeness and compliance. Drives consistency across projects/programs.
  • Manages service providers/contractors as needed.
  • Leads continuous improvement within the department and across the organisation. Uses submissions-related expertise to improve document quality and process efficiency. Ensures adherence of document to standards and processes.

Your Background: To join us as a MCS, you should have a working knowledge and understanding of the drug development process within the pharmaceutical industry, together with significant experience in an international communications or information role.

In addition, you will have:

  • Bachelor's degree in the life sciences, preferably with an MSc or PhD.
  • Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
  • Willingness to undertake domestic and international travel as required by the project.
  • Regulatory writing experience such as Clinical Study Reports.For more information or to apply for this position, please contact Lucy Stendall on 01246 457725 or email pharmacontracts@ckagroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 46957 in all correspondence.

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