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Senior Medical Writer

2 months ago


London, Greater London, United Kingdom MAC Clinical Research Full time
Senior Medical Writer

We are seeking a highly skilled Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will play a critical role in the development of clinical study documents, including protocols, informed consent forms, and clinical study reports.

Key Responsibilities:
  • Author, review, and edit clinical study documents to ensure accuracy and compliance with regulatory requirements
  • Collaborate with cross-functional teams, including biometrics, clinical operations, and sponsors, to ensure seamless document delivery
  • Provide mentoring and guidance to junior writers and perform expert document review and approval
  • Manage document review cycles, comment resolution, and incorporation to ensure inclusion of relevant input
  • Quality control - Provide peer review and quality control of draft and final documents against approved sources to ensure suitability for external distribution
Requirements:
  • Proven expertise in science and/or healthcare and knowledge of risk benefit
  • Ability to read, analyze, and interpret complex scientific and clinical information and write a clear, succinct summary targeted at the relevant audience
  • Excellent written and spoken English and the confidence to drive process improvements, best working practices, and Standard Operating Procedures (SOPs) to deliver to the highest quality standards
  • Computer literate - Word, PowerPoint, Excel, Teams, Sharepoint, Adobe
  • MSc or PhD in life sciences, medicine, pharmacy, or a related discipline
  • Previous experience of Medical Writing in a clinical research environment and knowledge of the relevant regulatory requirements
What We Offer:
  • Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
  • Health Insurance
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service)
  • Your birthday off work

MAC Clinical Research is an expanding full-service global CRO with an established network of 10 clinical trial sites in the UK. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have been in the Clinical Trials business for more than twenty years and are a relatively small organisation meaning we all know each other and are well placed to work collaboratively to provide a bespoke, agile service to our clients.