Principal Medical Writer - REMOTE

What Youll Be Doing

• 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

What Were Searching For

• Bachelors 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.
  
  Please apply on the Lifelancer platform at the below link for screening steps & quicker response.
  
  https://lifelancer.com/jobs/view/31e5bbb03553a48f9fa98744eed6b167