• Lead a group of writers assigned to a project, manage the greater project, and assign tasks to project team writers

• Act as lead writer; contributes to clinical and regulatory document creation, review the work of projects writers

• Act as principal liaison to project stakeholders

• Work with regulatory strategist(s) and other stakeholders to create submission strategies, timelines, for regulatory submissions (e.g. meeting packages, Investigational New Drug [INDs] applications, and sections of marketing applications [NDA/BLA/MAA])

• Creates clinical and regulatory documents according to ICH guidance

• Ensure timeline adherence of project writers and self, provide project status updates on a regular basis to stakeholders, leads and managers

• Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred

• 10+ years of medical writing experience in a pharmaceutical company or a contract research organization

• Maintains current knowledge of ICH and local regulatory authority drug research and development regulations

• Experience mentoring and training staff

• Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and relevant regulatory writing style