Principal Medical Writer (m/f/d)

Principal Medical Writer (M/W/D)

• Responsible for planning and preparing high quality medical writing deliverables and disclosure/transparency activities (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, Plain Language Summaries, Results Summaries for disclosure, briefing books).

• Participates in the development of Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables

• Provides input into the strategy for medical writing vendor selection, defines the scope of work to be outsourced and is responsible for medical writing vendor management.

• Responsible for continuous improvement of in-house medical writing

   

• A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development 

• An excellent understanding of all aspects of ICH GCP, SOPs, and international publication planning guidelines

• Successful track record of leading complex clinical / regulatory writing projects

• Able to work independently on CSRs and module 2 clinical documents

• Prior experience of working in the role of medical writer within the CRO/Pharma/Biotech industry

• As a guide, a minimum of 7 years Clinical experience in the role of medical writer

• Excellent level of English language proficiency

• Expert MS Office skills with a special focus on word processing , tables and graphics, spreadsheet presentations and template