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176 ICON Clinical Research Germany GmbH
last mo.

Principal Medical Writer(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeSenior

Description

As a Principal Medical Writer, you will lead the creation of essential regulatory documents, ensuring they meet industry standards while collaborating with diverse teams to support client submissions to regulatory authorities.

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Requirements

  • Bachelor's degree in life science discipline
  • Master's degree in life science discipline preferred
  • At least 6 years of medical writing experience in biopharmaceutical/CRO industry
  • Regulatory writing experience - Clinical Study Reports, IBs, Protocols
  • Oncology experience
  • Proficient understanding of domestic and international regulatory requirements
  • Proficiency in organizing and communicating clinical information
  • Strong communications, organizational, time management, and project management skills

Education

Bachelor's degree
OR
Master's degree

Work Experience

6 years

Tasks

  • Develop regulatory documents for global submission
  • Create Clinical Study Reports and Clinical Summaries of Efficacy and Safety
  • Draft Clinical Overviews in line with ICH guidelines
  • Manage medical writing projects and develop timelines
  • Communicate with cross-functional team members about review cycles
  • Participate in cross-functional meetings to discuss deliverables
  • Review project-related documents such as Protocols and Statistical Analysis Plans

Languages

EnglishBusiness Fluent

Benefits

More Vacation Days

  • Various annual leave entitlements

Healthcare & Fitness

  • Health insurance offerings

Retirement Plans

  • Competitive retirement planning

Mental Health Support

  • Global Employee Assistance Programme

Other Benefits

  • Life assurance

Additional Allowances

  • Flexible optional benefits
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