Urgent vacancy for B. Pharm / M.Pharm as Medical Writer
Qualification Required: B. Pharm / M.PharmExperience: 3+
Primary Responsibilities:
1. Prepare, edit and coordinate the production of Study Protocols.
2. Preparation of Protocol Synopsis with assistance of PI.
3. Developing Informed Consent Forms with adherence to protocol and Standard Operating procedures.
4. Develops study worksheets and source documentation tools.
5. Co-coordinating the ethics committee, who safeguard the rights, safety and
wellbeing of all trial subjects.
wellbeing of all trial subjects.
6. Interacts with Bioanalytical and Biostatiscian team for protocol inputs.
7. Coordinate activities of personnel within Clinical Supplies, Clinical Reference Laboratory, Medical Communications, Regulatory Affairs, and Quality
Assurance.
Assurance.
8. Briefing research staff on conducting the trial.
9. Providing Regulatory updates to Clinical team.
10. Preparation and Review of Clinical Study Reports.
11. Collection of AEs, Subject Disposition, Protocol Deviations, Dosing information from CRFs and TMFs.
12. Updating Safety database in MS Access.
13. Preparation of 2.7 Module tables as per regulatory requirements;
Forward your CV to
hr.cr@vimta.in
jagadeeswara.komiri@vimta.in
hr.cr@vimta.in
jagadeeswara.komiri@vimta.in
0 Comments