Job for Medical Expert at Novartis

A global healthcare leader, 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 : PLS Scientific BP & Medical Expert

Job Description
The PLS Scientific Business Partner and Medical Expert is responsible for providing scientific and medical guidance to PLS Scientific Services customers (role of Scientific/ Medical Expert). The incumbent will ensure the successful implementation and delivery of the PLS scientific and medical services along the key customer requirements (role of Scientific Business Partner). He/ She will be the Point of Contact (PoC) into PLS when medical/ scientific expertise is required into scientific, medical and literature services delivered by PLS to the customer. The incumbent has to demonstrate leadership in a globally distributed and matrixed organisation to ensure high performance and quality of delivered PLS scientific services and operations. Provide scientific and medical input for PLS scientific and medical services strategy.
• Enable excellence in scientific service delivery by strong matrix leadership across Global/Regional PLS organization and offshore service centers.
• Build and maintain a strong customer focus and collaboration with NGSCs as well as Global Product Leads and Global Process Owners to represent voice of customer in service development and delivery
• Serve as the PLS scientific and medical expert in interactions/meetings with Novartis Scientific and Medical organizations and other scientific committees and on customer 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 PLS supported projects.
• Ensure on-going operational excellence and continuity among scientific services and operations aligned delivery resources
• Serve as Medical Expert/ Scientific Advisor specifically for the following PLS services:
1. Provides medical and scientific input and contributes to development of study related documents for assigned interventional and non-interventional studies
2. Provides medical and scientific support to global/local development or medical affairs teams (Medical Advisor, GPMD, GBMD/GMAD) in their medical operations and medical plans
3. 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 the scientific, medical input and design of assigned protocol(s) within a program or section.
* 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).
• Clinical Medical Advisor: the PLS Medical Expert acts as medical expert and leader in interactions with internal stakeholders and decision boards from Novartis Divisions (e.g. Pharma Medical Affairs) and on demand external stakeholders - regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups.

Candidate Profile
MD or PhD
• Desirable: MBA or professional qualification
• Fluent spoken and written English
• 10+ 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, and clinical development process.
• ≥ 7 years technical and operational experience in planning, executing, reporting and publishing clinical studies in an international pharmaceutical company.
• Manage several 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).
• Significant experience of managing multi-functional scientific and medical projects, transitions, migrations with internal and external stakeholders

Additional Information:
Experience: 10+ years
Qualification : MD or PhD, MBA
Location : Hyderabad
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: Marketing
Job ID: 251745BR
Last Date: 10th November, 2018