by manjiri desai
October 14, 2022 |
61:28 |
Views: 4,580 |
PDUs: 1.00 |
Rating: 4.29 / 5
Medical writing and project management are two sides of the coins because one can write and produce quality documents to the regulators successfully only with managing the project effectively. The medical writer has to think because of the intellectual nature of the job, and one has to think through the concept, analyze, and interpret the data. This is not possible without coordinating with the core team members viz. clinician, clinical operations’ project manager, biostatistician, data manager, clinical research associates, publisher, research scientist, accounts and legal departments, facility (clinical site) staff, and the management of the Sponsor. At the same time confidentiality of the work and the information is of utmost importance before it comes in the public domain as this might involve the individual subject’s confidential information also!