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.