ICON Clinical Research Principal Regulatory Writer - Home based in Marlborough, Massachusetts

ICON is currently seeking a Principal Medical Writer with experience in regulatory submissions to be home-based anywhere in the European Union or United States.

  • To prepare clinical and regulatory documents, as a Lead Writer or in a support function, as required.

  • Participation in development of ICON’s service offering in* writing Clinical modules/summaries which form part of EU or US regulatory submissions eg MAA or NDA (Module 2.5, Module 2.7, ISS, ISE) A MUST*, including liaison with internal Business Development colleagues, identification of potential clients, input into proposals and contracts, attendance at bid defense meetings (face-to-face or via TC), preparation of modules/summaries, preparation of relevant SOPs/Working Procedures and training of less experienced writers.

  • To act as the point of contact between Medical Writing and both internal and external customers for specified projects.

  • To ensure projects are completed according to contractual obligations and in a profitable manner.

  • To oversee a portfolio of client projects, if assigned as Oversight Manager.

  • To ensure compliance with department metrics for quality and timeliness.

  • Participation in external and internal audits.

  • Training and development of less experienced Medical Writers.

  • Participation in other non-billable activities, as required.

  • Travel (approximately 20%) domestic and/or international.

  • To embrace and promote to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Any other task deemed reasonable by department senior management.