Report Writer - Biopharmaceutics & Project Management Department @ Veeda CR

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Report Writer - Biopharmaceutics & Project Management Department

Veeda CR
5 - 7 years
Ahmedabad
2 months ago
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Job Description

Role & responsibilities

Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates.
Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements.
Submit final compilation signed report with e-CTD to client.
Co-ordinate with Project Manager for report requirement, sponsor's comments & response.
Draft final report and submit to sponsors via project manager. Co-ordinate with BR for bio analytical report and stat for statistical report and submit sponsors via project manager.

Job Classification

Industry: Clinical Research / Contract Research
Functional Area / Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Pharmaceutical & Biotechnology - Other
Employement Type: Full time

Contact Details:

Company: Veeda CR
Location(s): Ahmedabad

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Keyskills: Regulatory Pharmacokinetics Report Writing CTD Project Reports Clinical Study Report

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Your name (*)

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

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Report Writer - Biopharmaceutics & Project Management Department @ Veeda CR

Home > Pharmaceutical & Biotechnology