Pharma Tips

Medical Writer

By: Pharma Jobs | Views: 2030 | Date: 02-Jun-2011

Neptune is a Global Staffing Company catering to the niche areas of IT/ IT-Enabled services. Located in Pune and having its operations across India, has successfully developed its relationship with leading multinationals. It is looking after the outsourcing of manpower and spreading its operations to important cost saving initiatives in India.

Neptune consultants , hiring for Reputed Client of Neptune Consultants

Summary
 

Experience:

2 - 7 Years

Location:

Mumbai

Education:

UG - B.Pharma - Pharmacy,B.Sc - Any Specialization, Bio-Chemistry, Microbiology, Statistics, Zoology,BDS - Dentistry,MBBS - Medicine PG - Any PG Course - Any Specialization,M.Pharma - Pharmacy,M.Sc - Any Specialization, Bio-Chemistry, Microbiology, Statistics, Zoology

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Documentation/Medical Writing

Functional Area:

Healthcare, Medical, R&D

Posted Date:

02 Jun

Desired Candidate Profile

- Knowledge of Medical/Life sciences

- Knowledge of ICH-GCP guidelines

- Computer Literacy ( good knowledge of MS Office)

- Excellent interpersonal and communication skills

- Ability to present the right and required information in a logical

  manner

 

Job Description

1.Initiate start up meetings with the Study Teams related to the

   creation and development of the clinical document for

   regulatory submission.

2. To work in coordination with all the members in the study

    team- internal and external for the development of clinical 

    documents.

3. Project timelines amongst the study team for the

    development of document.

4. Prepare Clinical Documents according to the Standard 

    Operating Procedures, Document Standards and Guidance  

    document.

5. Reviews statistical analysis plans and table/figure/listing.

6. Ensure uniformity and consistency in the scientific content of

    the  regulatory documents.

7. Revise the document as per the comments from the study

    team members.

8. Prepare the clinical documents with required quality 

    standards within the target timelines.

9. To work in coordination with the members in the study team

    for the quality check of the clinical documents.

10.Project timelines amongst the study team for the quality

     check of the document.

11.Perform the quality check of the clinical documents using the

     Clients latest quality checklist.

12. Send the annotated quality checked document to the author

      within the timelines.

 

Keywords: Medical writer, Clinical research, Clinical study report

Company Profile

Neptune is a Global Staffing Company catering to the niche areas of IT/ IT-Enabled services. Located in Pune and having its operations across India, has successfully developed its relationship with leading multinationals. It is looking after the outsourcing of manpower and spreading its operations to important cost saving initiatives in India.

Contact Details
Company Name:

Neptune consultants

Website:

Not Mentioned

Executive Name:

Nikita

Address:

Neptune consultants
Neptune Consultants
DATTAPRASAD APPT | 1206/B/7 | APTE ROAD |
Flat No 8 | Shivajinagar Pune-16
Pune,Maharashtra,India 411018

Telephone:

20-91-7350554272

Reference ID:

Medical Writer

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