Find freelancers. Lose those costly delays.

With 1.7 million freelancers, we'll match you with the perfect talent.

or, Register with Elance »

Nilesh Darekar | Elance
 
176985602337900
Last Sign-in: Jun 6, 2012

Nilesh Darekar

Masters in Pharmacology
   India
  |  10:32 am Local Time

Overview

Minimum Hourly Rate $22

Project Leadership : Provide leadership and guidance, trouble-shoot as necessary and provide problem-solving for all team members within each function on assigned projects.

Business Development :Assist with the preparation of cost estimates and proposals for clients. Attend client meetings, including bid defence meetings.


Quality : Responsible for the compliance of studies within assigned projects to statutory requirements.

Project Team Management : Accountable, on assigned projects, for the overall management of the project team by...

Read More »

Portfolio

Gold Medal for year 2007 2009 in M. Pharma. (Pharmacology)
http://www.hindu.com/2010/05/16/stories/2010051655770300.htm

Skills (4)

Tested
ISO 9001
Phase 1 - Phase III Clincal Research
ICH - GCP
US FDA; EMEA; TGA Clinical Regulatory Affairs

Service Description

Academic Experience:-
Expertise:-
Animal Handling Animal Model Handled
1. Rat 1. Cardiotoxicity 6. Catalepsy
2. Mice 2. Anti diabetic 7. Myocardial Infraction
3. Rabbit 3. Anorexic 8. Hepatoprotective
4. Guinea Pig 4. Ulcerative colitis 9. Inflammatory bowel Disease
5. Hamster 5. Nephrotoxicity 10. Anti-inflammatory

Industrial Projects during M. Pharma:-
Indication Models Handled
Anti-Diabetic Streptozotocin-induce diabetes
Cardiotoxicity Doxorubicin induce cardiotoxicity.
Inflammatory bowel Disease Indomithacine induce IBD
Anti-inflammatory Carraginan induce paw edema


Professional Experience:-

Member of Quality Assurance unit In Bombay Bioresearch Center.

Responsibilities handled
Regulatory and ethical submissions and procedures and communicating with relevant authorities
Implementation of the clinical trial from initiation through the stages of development documents, SOPs, tools, organization facilities and licenses
Monitoring and Review Clinical data
Review, checking of clinical data for submission of regulatory for clinical phase
Conducting internal and Vendor audits
Preparation of corrective action and preventive action (CAPA) report
Number of Healthy volunteer Clinical Projects :- 10
Number of projects successfully submitted to US FDA 1
Number of projects successfully submitted to WHO - 3
Number of projects successfully submitted to ANVISA 2
Number of Projects submitted to DCGI 3
Number of project for Non Regulatory submission -...

Read More »

Education

JN Medical College
M. Pharma
2007 - 2009

Keywords

clinical research
project management
Regulatory
Medical writing
US FDA
My Snapshot
Writing & Translation
1
Elance Level
Level represents activity and experience on Elance. Freelancers start at Level 1 and achieve higher levels through their work. A higher "Level" indicates greater earnings, ratings and other achievements on Elance. Learn More »
  • 12 months
  • Lifetime
Jobs
0
0
0
Total
Milestones
Hours
Reviews
Recommend
Clients
Total
Repeat
Earnings
Total
Per Client
Identity
Username
ndarekar
Type
Individual
Member Since
May 2012
Elance URL
Verifications
0
Nilesh Darekar | Elance

Nilesh Darekar