Medical Writer

5 days ago

London, Greater London, United Kingdom MAC Clinical Research Full time
Job Summary

We are seeking a highly skilled and experienced Clinical Regulatory Writer to join our team at MAC Clinical Research. As a key member of our team, you will be responsible for creating high-quality clinical documents for submission to regulatory authorities.

Key Responsibilities
  • Develop and finalize clinical documents, including investigator brochures, study protocols, informed consent forms, and clinical study reports.
  • Manage document review cycles, comment resolution, and incorporation to ensure inclusion of all relevant input.
  • Publish PDF versions of final clinical documents to approved standards.
  • Provide peer review and quality control of draft and final documents against approved sources to ensure suitability for external distribution.
  • Support the preparation of client meetings and teleconferences.
  • Participate in data-focussed discussions and collaborate with the project team to ensure deliverables are effectively planned and coordinated.
  • Identify potential risks and develop mitigation and contingency plans.
  • Drive medical writing discussions and lead key meetings with subject matter experts to achieve project deliverables on time and to high quality.
  • Review and provide input into project plans and documentation.
  • Support the participation of other members of the project team into Medical Writing deliverables.
  • Provide training and guidance to Associate Medical Writers.
  • Contribute to the writing, reviewing, and updating of departmental SOPs and associated forms and templates.
Requirements
  • Educated to at least Bachelor's degree level, preferably in life sciences, medicine, pharmacy, or a related discipline.
  • Previous Clinical Regulatory Writing experience (essential).
  • Knowledge of clinical study design, drug development, and the relationship between a clinical research organization, industry, and pharmaceutical clients.
  • Knowledge of or experience in the conduct of clinical trials.
  • Passion for science and healthcare and an understanding 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.
  • Ability to understand mathematical concepts such as probability and statistical inference.
  • Ability to write articles for peer-reviewed publications that conform to the prescribed journal style and format.
  • Ability to work in a collaborative team environment and support colleagues to achieve high-quality outcomes.
  • Well-organized, flexible, and able to plan and work effectively to tight deadlines.
  • Excellent interpersonal skills, including written English and clear oral communication.
  • A keen eye for detail across scientific content, consistency, and editorial standards.
  • Ability to manage and prioritize multiple projects simultaneously.
  • Computer literate – Word, PowerPoint, Excel, Teams, Sharepoint, Adobe.
Desirable Criteria
  • PhD in life sciences, medicine, pharmacy, or a related discipline.
  • Previous experience of Medical Writing in a clinical research environment and knowledge of effective Medical Writing Practices.
  • Previous experience working as a Medical Writer on Protocol and CSR projects across Phases 1-3 and various therapy areas, including mental health and psychedelic drugs.
  • Experience in the technical aspects of document formatting, Adobe Acrobat for signatures and manipulation of PDFs, use of reference manager, and collaborative authoring tools.
  • Knowledge of the regulatory framework that surrounds drug development and the clinical trial process, including the interaction between Medical Writing, Biometrics, and Clinical Operations.
Benefits
  • Competitive salary in keeping with pharmaceutical industry standards that will reflect experience.
  • Health Insurance.
  • Free onsite parking.
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service).
  • Your birthday off work.

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