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Education: UG - B.Pharma - Pharmacy,B.Sc - Any Specialization,BDS - Dentistry,MBBS - Medicine PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Job Description
Role and Responsibilities:
Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission.
To work in coordination with all the members in the study team- internal and external for the development of clinical documents.
Project timelines amongst the study team for the development of document.
Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document.
Reviews statistical analysis plans and table/figure/listing.
Ensure uniformity and consistency in the scientific content of the regulatory documents.
Revise the document as per the comments from the study team members.
Prepare the clinical documents with required quality standards within the target timelines.
To work in coordination with the members in the study team for the quality check of the clinical documents.
Project timelines amongst the study team for the quality check of the document.
Perform the quality check of the clinical documents using the Clients latest quality checklist.
Send the annotated quality checked document to the author within the timelines.
Keywords: Clinical Trials Writing.
Desired Candidate Profile
Prepare clinical documents that are part of regulatory submission that include Clinical Study Report, Clinical Trial Registry Summary, Narratives and Post Approval Documents across the Therapeutic Areas.
Quality check of the clinical documents that are part of regulatory submission that include Protocol, Clinical Study Report, Clinical Trial Registry Summary, Clinical Summary of Safety and Clinical Summary of Efficacy.
Company Profile
Neptune is a Recruitment Firm.
Contact Details
Company Name: Neptune consultants
Executive Name: Pooja Shinde
Address: Neptune Consultants
DATTAPRASAD APPT | 1206/B/7 | APTE ROAD |
Flat No 8 | Shivajinagar Pune-16
Pune,Maharashtra,India 411018
Email Address: pooja@neptuneconsultants.com
Telephone: 20-91-9011088838
Reference ID: "Medical Writer"