Report writer(Regulatory Affair)

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One of our Client's Company
Job Info
Job Status: Open
No of Vacancies: 3
Date Posted: January 9, 2019
Expiry Date: January 31, 2019
Job Type: Full Time
Job Level: Any
Years of Experience: 4
Salary Info
Salary Type: Negotiable
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Position-Report writer(Regulatory Affair)


Male Candidates preferred

Job Description:

  • 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.