Medical Writer Neptune Consultants

By: Pharma Jobs | Views: 2720 | Date: 23-Aug-2011

Job detail for the post of Medical Writer in Neptune consultants Mumbai, 1 to 5 years of experience. Apply for the job Now ! Search Jobs in India by Functional Area, Industry and Location. Search Jobs in India - Delhi, Mumbai, Bangalore, Kolkata. Find career openings in top companies. Post your resume and find your dream job Now !.

Experience:

1 - 5 Years

Location:

Mumbai

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

Role:

Bio-Statistician

Functional Area:

Healthcare, Medical, R&D

Posted Date:

23 Aug

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

Website:

Not Mentioned

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"

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