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.
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.
• 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
• 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
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
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