Job Description :
The Medical Writer will perform the following activities:
Develop protocols, clinical study reports, investigators brochure, informed consent documents and other regulatory documents as per SOPs and applicable style guides.
Handle at least 2 projects in a month.
Coordinate with data management, project management, medical monitoring and regulatory teams during development of project deliverables.
Coordinate with Sponsor from initialization to finalization of project deliverables.
Update senior medical writer of project status.
Keep pace with regulatory guidance and client expectations, and to improve skills.
Participate in the business development meetings.
Review regulatory documents prepared by the Junior Medical Writer and assist them in developing documents.
Provide relevant training to new employees.
Have a good knowledge of drug development process and regulatory guidelines.
Develop good working relationships with internal and external colleagues
The Medical Writer will perform the following activities:
Develop protocols, clinical study reports, investigators brochure, informed consent documents and other regulatory documents as per SOPs and applicable style guides.
Handle at least 2 projects in a month.
Coordinate with data management, project management, medical monitoring and regulatory teams during development of project deliverables.
Coordinate with Sponsor from initialization to finalization of project deliverables.
Update senior medical writer of project status.
Keep pace with regulatory guidance and client expectations, and to improve skills.
Participate in the business development meetings.
Review regulatory documents prepared by the Junior Medical Writer and assist them in developing documents.
Provide relevant training to new employees.
Have a good knowledge of drug development process and regulatory guidelines.
Develop good working relationships with internal and external colleagues
Desired Candidate Profile :
UG - B.Sc - Any Specialization, BDS - Dentistry, BVSC - Veterinary Science, MBBS - Medicine
PG - M.Sc - Any Specialization, MVSC - Veterinary Science, M.S/M.D - Any Specialization, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization
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