Clinical Study Report – Clinical Pharmacology

Clinical Study Report (CSR) Writing

We have an amazing client looking for a CSR Writer to support a full Clinical Study Report writing for Phase 1, development and preparation of regulatory Modules (2.7.1/2.7.2). They are looking for strong scientific writing skills, a key attention to detail and inspection‑ready deliverables.

We have an amazing client looking for a CSR Writer to support a full Clinical Study Report writing for Phase 1, development and preparation of regulatory Modules (2.7.1/2.7.2). They are looking for strong scientific writing skills, a key attention to detail and inspection‑ready deliverables.

• All deliverables are inspection ready and compliant with regulatory guidelines
• Maintain planning for writing and QC deliverables
• Highlight any process improvements to enhance collaboration between CPP and document Service Teams
• Excel in shell creation and timeline management
• Create QC reports
• Interpret clinical and statistical outputs

• Strong experience in report writing and QC procedures
• Formal communication skills
• Excellent knowledge of formatting on Word

• Understanding of PK/PD analysis tools
• Working understanding of Phoenix Win Nonlin

If you are a contract freelancer in CSR or looking to move into this sector please apply below and I would love to hear from you to discuss the vacancy further.