£50 - £60 per hour
3 months ago
A world-famous bespoke manufacturer of medical technology has an urgent requirement for an Interim Medical Writer
This is an initial interim contract running until the end of the year offering up to £60 p/h. This is a part time role average of 10 hours per week which could range from 5 to 20 hours per week. The business is based in Watford but this role can be undertaken remotely.
- Participate in the overall effort to update nonclinical and clinical dossier sections for pharma products and respond to health authority questions.
- Draft Module 2/4/5 nonclinical and clinical dossier sections, including overviews and summaries, based on detailed study summaries/assessments provided by the nonclinical and clinical subject matter experts (SMEs).
- Review/revise drafted Module 2/4/5 sections to align with regulatory requirements and best practices.
- Ensure Module 2/4/5 documents are submission-ready by reviewing for consistency, clarity, and proper formatting,
- Update the Summary of Product Characteristics and Patient Information Leaflet in line with dossier updates
- Be available for regular teleconferences with nonclinical and clinical drafting teams
- Provide finalized documents to the publishing group.
- Participate in regular teleconferences with the Regulatory Affairs Manager to report on project status and ensure alignment with project objectives and milestones.
- Minimum 5 years' experience as a medical writer
- Experience in submission of ECTD modules 2, 4 & 5 for pharmaceutical products
- Experience with submissions to the EMEA
- Experience with the summary of product characteristics & patient information leaflets
- Desired - A candidate that has devised or been a part of a clinical strategy drafting or implementing for a product for EMEA submissions
This is an extremely urgent requirement so if it is of interest please apply immediately or contact Jamie.email@example.com to find out more.