Summary
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
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
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