Position-Report writer(Regulatory Affair)
Male Candidates preferred
- Design study protocols including study synopsis based on clinical inquiry, tracking project timelines & ensuring the timely delivery of project protocols.
- Extensive literature search in designing sampling time points and sample size justifications
- To work in coordination with all the members in the study team- internal and external for the development of the protocol.
- Inputs to statistical analysis plans.
- Ensure uniformity and consistency in the scientific content of the regulatory documents.
- Revise the document as per the comments from the study team members (external and internal).
- Prepare the clinical documents with required quality standards within the target timelines.
- To work in coordination with the members of the study team for the quality check of the clinical documents.