Required Attributes : Graduate/ Masters in Life Science, B Pharma/ M/ Pharma with minimum 4 years of experience. Key responsibilities: ...
1. Independently develop and finalize documents of the study, and scientific documents for different regulatory submissions such as study protocol and EC documents. Bioanalytical reports, Clinical Study Reports (CSRs), part of Electronic Common Technical Document (eCTD) modules covering various therapeutic areas, and phases of clinical research, collaborating with internal and external clients to support and enable effective communication resulting in operational excellence.
2. Oversee and manage the planning, execution, and completion of clinical trials, bioavailability, and bioequivalence studies within a cross-functional team to ensure the successful execution of study projects. This involves coordinating with various departments, including clinical and bioanalytical teams, and Quality Assurance concerning study submissions.
3. Coordinate with sponsors concerning study synopsis, study protocol and protocol approvals, and comprehensive reports. EC submissions and EC coordination.
4. compliance with ethical committee standards and regulatory obligations throughout the study.
5. Ensure that project deliverables are achieved in accordance with the agreed terms and within the specified turnaround time for the sponsor.
6. Address client inquiries related to investigational products, project specifics, and regulatory matters.
7. Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable.
8. Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings .
experience
8show more Required Attributes : Graduate/ Masters in Life Science, B Pharma/ M/ Pharma with minimum 4 years of experience. Key responsibilities:
1. Independently develop and finalize documents of the study, and scientific documents for different regulatory submissions such as study protocol and EC documents. Bioanalytical reports, Clinical Study Reports (CSRs), part of Electronic Common Technical Document (eCTD) modules covering various therapeutic areas, and phases of clinical research, collaborating with internal and external clients to support and enable effective communication resulting in operational excellence.
2. Oversee and manage the planning, execution, and completion of clinical trials, bioavailability, and bioequivalence studies within a cross-functional team to ensure the successful execution of study projects. This involves coordinating with various departments, including clinical and bioanalytical teams, and Quality Assurance concerning study submissions.
3. Coordinate with sponsors concerning study synopsis, study protocol and protocol approvals, and comprehensive reports. EC submissions and EC coordination. ...
4. compliance with ethical committee standards and regulatory obligations throughout the study.
5. Ensure that project deliverables are achieved in accordance with the agreed terms and within the specified turnaround time for the sponsor.
6. Address client inquiries related to investigational products, project specifics, and regulatory matters.
7. Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable.
8. Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings .
experience
8show more
