Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Associate Medical Expert - T&MO
Job Description
• Build and maintain a strong business colleague focus and collaboration with NGSCs as well as Global Product Leads and Global Process Owners to represent voice of business colleague in service development and delivery
• Attend meetings with Novartis Scientific and Medical organizations and other scientific committees and on business colleague’s request participate in meetings with external experts/investigators and key opinion leaders.
• Provide scientific and medical expertise during regulatory agency inspections and internal audits for T&MO supported projects. Contribute to continuous service improvement initiatives in M&CS
• In collaboration with appropriate Clinical Trial Team (CTT) members: ensures direct medical support for assigned interventional and non-interventional studies as needed and may act as medical monitor:
• Contributes to development of study protocol and regulatory documents - Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities, supports medical review, reporting of quality data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH, and regulatory requirements.
• Provides clinical leadership and medical input for clinical deliverables in assigned protocol(s).
• Contributes to clinical/scientific content of clinical communications and publications related to assigned trial(s). Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentation
Candidate Profile
• 5+ years in Clinical Development / Medical Affairs areas with hands on experience in at least two different therapeutic areas.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, clinical development process.
• ≥2 year’s technical and operational experience in planning, executing, reporting and publishing clinical studies in an international pharmaceutical company.
• Manage trials in parallel with multidisciplinary trial teams in a matrix organization
• Medical expertise appropriate to main therapeutic areas of Novartis
• Demonstrates ability to establish strong scientific partnership with key internal and external stakeholders
• Preferred: experience in remote relationships (on-shore/off-shore capability delivery).
Additional Information
Experience : 5+ years
Qualification : M.Pharm, M.Sc, B.Pharm
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
End Date : 25th June, 2021
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