Job Description:
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- Supports medical writing activities for Clinical Study Report (CSR) production following specified processes, guidelines, and templates utilized by the company - conforming to ICH-E3 guidelines and the company’s Global Document Style Guide
- Liaises with CPW Medical Writing Point of Contact (PoC) for adhering to timelines and ensuring all requirements of the CSR are met
- Participates in regular study team meetings when CSR topics are discussed
- Coordinates review meetings as required with clinical study team to review CSR and collect comments for incorporation into the CSR
- Ensures CSRs accurately reflect the data presented in the statistical tables and listings and other information sources
- Develops and maintains knowledge of all applicable global regulations and guidelines, SOPs and practices
- 4-7 years of experience working on Oncology writing
- Experienced supports medical writing activities for Clinical Study Report (CSR) production following specified processes, guidelines, and templates
- Experienced liaising Medical Writing Point of Contact (PoC) for adhering to timelines and ensuring all requirements of the CSR are met
- Experienced participating in regular study team meetings when CSR topics are discussed
- Experienced coordinating review meetings as required with clinical study team to review CSR and collect comments for incorporation into the CSR
- Experienced ensuring CSRs accurately reflect the data presented in the statistical tables and listings and other information sources
- Experienced developing and maintaining knowledge of all applicable global regulations and guidelines, SOPs and practices
Please Include Job Title and Location in the Subject Line of Your Email