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Freelance Regulatory/Clinical Medical Writer

  • Job type: Contract
  • Location: Slough, Berkshire
  • Salary: Competitive
  • Job reference: 347773/004_1540840815
  • Sector: EPM Scientific, Regulatory
  • Date posted: 29/10/2018

***A Global Biotech company in the UK is looking for 4X Freelance Regulatory/Clinical Medical Writers to take part in a 6 Month Home-Based Project, starting ASAP***



Responsibilities:

  • Clinical submissions documents in scope include: Phase 1-3 protocols and clinical study reports (CSRs)

  • summary documents (including Integrated Summary of Safety [ISS]

  • Integrated Summary of Efficacy [ISE]

  • Clinical Overview, Clinical Summary)

  • risk management plans (as needed)

  • Clinical study summaries (for posting to study registries)

  • Clinical parts of Investigational Drug Brochures

  • Agency meeting briefing packages

  • INDs, IND, and EU Annual Safety Updates, and responses to agency questions

Skills and Experience Required

  • MSc. or PhD degree or equivalent in related field.

  • Excellent command of English.

  • Expert knowledge of medical, pharmaceutical, and clinical research concepts.

  • Familiarity with statistical and data output.

  • Expert knowledge of the methods, techniques, and procedures of medical writing tasks.

  • Prior CSR and Summary Document generation experience.

  • Prior experience with submissions in Common Technical Document (CTD) format.

  • Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).

  • Detailed and experienced-based understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content.

  • Detailed and experience-based understanding of applicable regulations and guidelines

  • Ability to travel if required.

What this Job Offers You

  • 6 Month Contract

  • Flexibility (full-time-Part-time)

  • The opportunity to work from home

How to apply

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact or phone +442037588916.

Only candidates with the right to work in the EU or a full valid visa will be considered.

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