New London, CT - CPW Medical Writer

Job Description:

• 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

REQUIREMENTS:

• 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

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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