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Principal Medical Writer(m/w/x)
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
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
- ICON plcFull-timeRemoteSeniorFrankfurt am Main
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Principal Medical Writer(m/w/x)
The AI Job Search Engine
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.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
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
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
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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