Medical Advisor
MakroCare Pharmaceutical, Biotechnology and Medical Device industrie
Job description
MakroCare
is an Expert Strategic Development and Commercialization Global Partner for
Pharmaceutical, Biotechnology and Medical Device industries. Our Experience,
Programs and Processes bring a New Dimension to Development Strategy,
Regulatory/Risk Planning & Management, Clinical Research,
Medical/Scientific Support and Emerging Region Expansion www.makrocare.com
Experience;
0-2 years
Qualification:
MD Pharmacology or PhD. Pharmacology
Responsibilities:
Advise on
clinical and medical area inputs in designing clinical trials for drugs (both
new and post approval)and devices.
Review
clinical study documents (like protocols, study synopsis, labeling) for
scientific accuracy and suggest
improvements.
Undertake
protocol and product briefing and interact with other departments medical
writing,
clinical
data, biostatistics, medical device, scientific, CDM, BioStats.
Support
in effort estimation for Safety Queries, preparation of CSR, articles for
publications and other
materials as and when required.
Perform
detailed literature search (focusing on pharmacology, patient groups, safety,
labeling, etc)utilizing both public and private databases and show apt while
synthesizing the results needed for clinical designs to cover safety,
performance, efficacy and effectiveness of drugs/devices.
Coordinate
with medical writers (and other cross-functional teams) in the data review,
analysis and reporting of studies.
Be
responsible, in conjunction with other teams, for overall content and accuracy
of study report before forwarding for final sign-off. Assist with internal and
external dissemination of results to Development Team, Investigators etc.
Provide
mentoring, and training for other team members.
Work with
multinational project teams and coordinate activities on multiple projects.
Function
independently with initiative and minimal guidance.
Have
attention to detail and focus on quality.
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