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Friday, October 1, 2010

Deputy Manager-Medical & Scientific Affairs 1 Opening(s) Piramal Life Sciences Limited

Summary

Experience:
1 - 2 Years
Location:
Mumbai, Mumbai Suburbs
Compensation:
Rupees 5,50,000 - 7,00,000
Education:
UG - MBBS - MedicinePG - M.S/M.D
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Clinical Research Associate/Scientist
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

Reporting to: Medical Lead (metabolic disorders)

Education: MBBS with postgraduation in pharmacology or pharmaceutical sciences (M.S from US or Dip. Pharm Med. Royal college-UK) preferably course or diploma in clinical research

Experience: Experience of 1-2 yrs in medical affairs of clinical research department as executive with a leading CRO or research based pharmaceutical organization

Salary will depend on qualifications and experience.

 

Job Description

The job will involve assisting in the following areas:
  • Planning and overall management all aspects of clinical study plan, end-points and conceptualize clinical study design, including adaptive designing
  • To lay down strategic foundation for protocol, CRF and clinical study report preparation.
  • Identify expert panel for suggestions on clinical strategy
  • Organize Investigator Meetings to finalize plan
  • Identify and implement actions to keep projects on track e.g. interim analysis of reports, decide on ongoing project based on results available at hand,
  • Critical evaluation of CROs and identify right CROs and/other vendor selection.
  • Interface with project team members including: Drug Supply, Regulatory, Data Management, Statistics, Drug Safety , Finance Departments
  • Ensures knowledge and implementation of new external or internal procedures
  • Liasoning with Cross-functional teams like IND team, pre-clinical, formulations, toxicology, medicinal chemistry, pharmacology, Pk/Pd and others
  • Handle presentations to regulatory authorities and lead scientific discussions ith various regulatory authorities including but not limiting to DCGI, US-FDA, MHRA, other EU authorities wherever required
Keywords: clinical study plan; study design; medical scientific affairs; investigator meetings

Company Profile

Piramal Life Sciences Limited “We dream of making a difference to the quality of life by reducing the burden of disease.” The community at Piramal Life Sciences Limited aspires to reach catalytic innovation to the broader masses, in India and across the world. It has embarked upon an ambitious programme to discover and develop new chemical entities (NCEs) and Novel Drug Delivery Systems (NDDSs) in select therapeutic areas, including Cancer, Inflammation, Diabetes / Metabolic Disorders and Infectious Diseases with a pipeline of 14 molecules in different phases of development. 
Piramal Life Sciences Limited hopes to provide affordable drugs not just to India but also to the rest of the world.
Contact Details
Company Name:
Piramal Life Sciences Limited
Address:
1, Nirlon Complex, Off W. E Highway,
Goregaon East
MUMBAI,Maharashtra,India 400063




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