ICON plc
Clinical Research Lead Assistant(m/w/x)
Full-timeRemoteSenior
Frankfurt am Main
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17176 ICON Clinical Research Germany GmbH
Principal Medical Writer(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Nejo AI Summary
Drafting regulatory documents for global submission, including Clinical Study Reports and Overviews, with project management. 6+ years medical writing experience in biopharmaceutical/CRO industry, with oncology experience, required. Global Employee Assistance Programme.
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
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
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business 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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 176 ICON Clinical Research Germany GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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17176 ICON Clinical Research Germany GmbH
Principal Medical Writer(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Nejo AI Summary
Drafting regulatory documents for global submission, including Clinical Study Reports and Overviews, with project management. 6+ years medical writing experience in biopharmaceutical/CRO industry, with oncology experience, required. Global Employee Assistance Programme.
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
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
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business 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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 176 ICON Clinical Research Germany GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
176 ICON Clinical Research Germany GmbH
Industry
Healthcare
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization focused on innovative treatments.
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