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Medical Writing Specialist

Employer
CK Group
Location
Berkshire
Salary
£38-55 per hour PAYE/Umb
Closing date
4 Feb 2021

View more

Sector
Medical Communications
Contract Type
Contract
Hours
Full Time

Job Details

CK Clinical are recruiting for a Medical Writing Specialist to join a biopharmaceutical company, on a contract basis for 12 months as a remote based writer.

The Company:

This company is a world leading pharmaceutical company that focuses on neurology and immunology. Their ambition is to transform the lives of people living with severe diseases.

Location:
Flexible remote/home working is available for this medical writer position.

Rate:
£38-55 per hour PAYE/Umbrella.

Medical Writing Specialist Role:
  • Provide QC support to writing functions ensuring compliance with Standard Operating Procedures (SOPs), FDA, EMEA, ICH, and national and local regulations, as applicable.
  • Manage and perform QC of clinical submissions documents such as Phase 1-4 protocols and clinical study reports (CSRs), summary documents, risk management plans (as needed), patient narratives, and clinical parts of Investigational Brochures, agency meeting briefing packages, INDs, and responses to agency questions, lay summaries, and redacted documents.
  • Provide expertise on process, content, checklists, efficiencies, timelines, and interdependencies.
  • Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the QC of clinical submissions documents, including SOPs, templates, and document writing conventions and styles.
  • Coordinate with other Medical Writing Specialists as needed to maintain consistency across documents within a project and across indications. Identify trends in quality deficiencies and recommend corrective actions.
  • Use functions of Electronic Document Management Systems (EDMS) and Please review for quality review, electronic formatting, compiling and finalizing of medical writing deliverables.

Your Background:
  • Bachelor's degree (Life Sciences preferred).
  • A professional certification (e.g. AMWA, EMWA, RAPS, BELS) is a plus, but not essential.
  • Extensive experience performing quality checks to medical writing functions.
  • Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process.
  • A high degree of familiarity with statistical and data output.
  • Intermediate understanding of applicable regulations and guidelines (e.g. Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content.

Apply:
For more information or to apply for this Medical Writing Specialist position, please contact CK Group, quoting job ref 49556.

It is essential that applicants hold entitlement to work in the UK.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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