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.