The Senior Medical Writing/ Document Specialist is responsible for the compiling, tracking, quality control and timely completion of the document components for these complex medical writing projects and for training new Medical Writing Specialists. These projects include Medical Research Reports (MRRs - synonym : Clinical Study Reports - CSRs),Clinical Trial protocols, protocol amendments, and key Regulatory Submission documents such as CTDs and INDs. Responsibilities also include training new Medical Specialists and exploring methods to increase job efficiency and develop quality improvement techniques, together with the Manager/Sr. Manager, Medical Process Management and Medical Writing and the Vice President of Clinical Pharmacology.
Responsible for providing support to the Clinical Pharmacology (CP) Study Managers by maintaining critical Clinical Pharmacology Clinical Trial Study Files and Documents as per Regulatory SOPs and also managing the study related databases such as MDD.
• Uses project management skills to compile, track, review and ensure timely completion of high quality MRRs (CSRs) prepared in the department or by external writers, clinical trial protocols , amendments to protocols and integrated study protocols according to SOPs.