Location – Hyderabad #LI Hybrid
About the Role:
The Associate Medical Expert will ensure the successful implementation and delivery of the Medical and Knowledge Solutions (MKS) scientific and medical services along the business colleagues’ requirements. He/ she is expected to support MKS when medical/ scientific expertise is required for scientific and medical services delivered by SW & MA to the business colleagues. The associate is expected to demonstrate standard of Medical and Scientific input to ensure dedicatione and quality of delivered SW&MA services and operations.
• Provides medical and scientific support development or medical affairs teams (Medical Advisor, GPMD, GBMD/GMAD) in their medical operations and medical plans.
• Act as medical lead in interactions with internal stakeholders from Novartis Divisions (e.g. Medical Affairs) and on demand external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups).
• Provide project based medical advisory services to global/country medical organization for driving global/country medical plans as standalone or along with medical communication and other team.
• Serve as scientific advisor specifically 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.
• 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.
• Provide scientific and medical expertise during regulatory agency inspections and internal audits for Scientific Writing and Medical Advisory supported projects.
• Build and maintain a strong business colleague focus and collaboration with NOCCs, Global Product Leads and Global Process Owners to represent voice of business colleague in service development and delivery.
Diversity & Inclusion / EEO
• Education (minimum): MBBS/MD.
• 8+ 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.
• Manage trials in parallel with multidisciplinary trial teams in a matrix organization.
• Efficient and timely execution of assigned trial protocols and related documents, in compliance with international and local regulations and Novartis internal standards.
• Demonstrates excellent scientific writing skills to enable the development of quality clinical protocols, trial reporting, and regulatory documents (no avoidable amendments).
• Demonstrates knowledge and application of statistical analysis methodology and can identify trends to effectively interpret / report data.
• Applies effective clinical research methodology, including study design/analyses, efficacy endpoints, safety assessments across disease area and development phases.
• Ability to work, prioritize, and drive projects independently.
• Ability to manage multiple projects and partners.
To apply for this job please visit www.novartis.com.