Hendre Moolman at CK Clinical is recruiting for a Senior Medical Writer to join a pharmaceutical company based in Buckinghamshire, UK on a permanent basis.
Senior Medical Writer Job Description
As Senior Medical Writer, you will author or assist with the authoring of regulatory documents for clinical research, including clinical study reports, clinical summary sections of common technical documents, investigator brochures, protocols and other clinical documents. Further responsibilities of this Senior Medical Writer position include:
- Compiling and assembling components (appendices, attachments, tabulated summaries) of clinical documents, including clinical study reports, clinical protocols, investigator’s brochures and CTD clinical summary documents for marketing applications.
- Under the supervision of senior staff, responsibilities may include performing a quality control review of components of clinical documents and performing other medical writing tasks as needed.
- Preparing clinical study reports for phase 1, 2, and 3 clinical research studies in support of regulatory submission of drugs and biologics worldwide.
- Acting as the lead writer for key clinical study reports, clinical trial protocols, investigator brochures, and other clinical documents.
- Coordinating compilation of required attachments and appendices, and oversees review and final publication.
- Working with all contributing departments to ensure that all necessary information is organized and summarized effectively.
- Ensuring that clinical study reports accurately reflect study results and coincide with R&D strategies and regulatory requirements.
- Serving as lead writer on regulatory filings and other large medical writing projects.
How to apply:
To find out more about this Senior Medical Writer position, please contact Hendre Moolman on 01438 743047 or email email@example.com. Please quote reference CL23556 in all correspondence.