IQVIA
Principal Statistical Programmer - FSP(m/w/x)
Full-timeOn-siteSenior
Frankfurt am Main
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IQIQVIA
Principal Medical Writer – Clinical Pharmacology(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Authoring full Phase 1 Clinical Study Reports and regulatory modules (2.7.1/2.7.2) at a global CRO. Strong experience with Phase 1 CSR and Module 2.7.1/2.7.2 writing required. Flexible remote work.
Requirements
- Strong experience in full CSR writing for Phase 1 clinical pharmacology studies
- Strong experience in protocol writing and Module 2.7.1/2.7.2 (SBAAM/SCP) writing
- Proficiency with Word templates and document formatting
- Experience authoring Health Authority responses
- Proficiency in Word templates and document formatting
- Excellent oral and written communication skills in English
Tasks
- Write full Clinical Study Reports (CSRs) for Phase 1
- Develop protocols
- Prepare regulatory modules (2.7.1/2.7.2)
- Ensure deliverables are inspection-ready
- Ensure compliance with regulatory and internal guidelines
- Maintain central planning for document writing
- Maintain central planning for QC deliverables
- Recommend process improvements to enhance team collaboration
- Drive document shell creation
- Drive quality control (QC) processes
- Drive timeline management
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Word
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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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IQIQVIA
Principal Medical Writer – Clinical Pharmacology(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Authoring full Phase 1 Clinical Study Reports and regulatory modules (2.7.1/2.7.2) at a global CRO. Strong experience with Phase 1 CSR and Module 2.7.1/2.7.2 writing required. Flexible remote work.
Requirements
- Strong experience in full CSR writing for Phase 1 clinical pharmacology studies
- Strong experience in protocol writing and Module 2.7.1/2.7.2 (SBAAM/SCP) writing
- Proficiency with Word templates and document formatting
- Experience authoring Health Authority responses
- Proficiency in Word templates and document formatting
- Excellent oral and written communication skills in English
Tasks
- Write full Clinical Study Reports (CSRs) for Phase 1
- Develop protocols
- Prepare regulatory modules (2.7.1/2.7.2)
- Ensure deliverables are inspection-ready
- Ensure compliance with regulatory and internal guidelines
- Maintain central planning for document writing
- Maintain central planning for QC deliverables
- Recommend process improvements to enhance team collaboration
- Drive document shell creation
- Drive quality control (QC) processes
- Drive timeline management
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Word
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA 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
IQVIA
Industry
Pharmaceuticals
Description
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Not a perfect match?
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