Job Description Summary
Direct and lead the professional clinical science base for the Emerging Markets Cluster; to efficiently and effectively deploy resources to support the business; to oversee all strategic and operational activities for Medical Affairs including for all phases of global development; to develop and manage long-term relationships with local Medical Experts and other external stakeholders as a key element of the medical strategy. To provide thorough up-to-date medical, clinical, and relevant scientific expertise to drive Novartis message delivery to key influencers and stakeholders; to collaborate with Country, Cluster, Regional and Global team members to support the execution of relevant Medical and clinical activities in assigned project(s).
Job Description
Major accountabilities:
1)To maintain and drive the standards of medical and scientific excellence in the cluster cross divisionally through recruitment, training, deployment and development of subordinate associates.
2)To ensure the necessary training and awareness of relevant associates so that Novartis maintains compliance with current legislation (and Codes of Practice) for promotional activities.
3)To represent the Cluster medical and scientific interests in internal and external (incl. HQ) forums.
4)To act as sponsor and contributor to relevant Local and Global Business initiatives.
5)Ensure long-term clinical strategy and planning: portfolio growth, business partnerships.
6)Ensure dissemination of trial-generated medical information to educate key influencers, including scientific and regulatory leaders.
7)To maintain full compliance with adverse event reporting to meet statutory regulations.
8)To be part of the development of the overall long-term strategy for the country and define a “roadmap” for medical activities.
9)To ensure adherence to financial and headcount targets for MA in the country.
10)To develop and maintain KOLs and investigators in clinical studies.
11)Accountable for local adherence to compliance standards (e.g., Be Sure) and local regulations across divisions.
12)As key member of the executive committee, to interact with other management members successfully to ensure highest possible market presence and penetration of Novartis products.
13)To contribute to mapping/ profiling of KOLs/ decision makers in line with segmentation, to develop professional relationships, build advocacy and gain contributions of KOLs/ decision makers.
14)To provide and discuss scientific information and data to healthcare professionals to ensure quality and accuracy of medical and scientific information on new treatment options including Novartis products and selected areas of therapeutic interest.
15)To liaise and provide up-to-date medical support to relevant external groups to facilitate listing of products in medical guidelines, formularies to impact pricing and health economic discussions.
16)To provide speaker training to health care professionals to support the best use of new therapies developed and commercialized by Novartis.
17)To provide medical support and training (i.e., disease state and product) to Novartis employees and collaborate with Novartis colleagues to actively support medical and scientific meetings by collecting and interpreting data/ insights /presentations/ results.
18)Observe strictly any and all applicable internal and external regulations, acts and procedures, including, but not limited to: Doing business ethically, Internal rules, Code of Ethics, Conflict of Interests etc.
19)Responsible for proper and compliant reporting of Adverse Events in order to fulfill all regulatory requirements and ethical obligations including timely forwarding of all spontaneous reports to local Drug Safety Responsible.
20)Comply with the GxP quality requirements applicable to his/her area of responsibility, incl. but not limited to proper reporting of adverse events and customer complaints, samples handling as well as any incident that may adversely affect the quality, safety, identity, strength, purity, availability or efficacy of a commercial product or clinical trial material and/or may compromise the Novartis Quality System and the global Novartis reputation.
Key performance indicators:
Minimum Requirements:
Work Experience:
Skills:
Experience:
• Solid medical background, at least 5 years of relevant experience
• At least 3 years in pharmaceutical industry with a track record participating in teams responsible for both medical and drug development support
• Demonstrated leadership skills with a track record of successful management of costs and headcount
• Sales/marketing experience is an advantage
• Excellent understanding of local regulatory standards and processes, as well as relevant ethical and legal guidelines. Ability to ensure compliance with these external guidelines as well as internal standard operating procedures
• Extensive knowledge of all aspects of drug development, GCP and local regulations, including regulations of Promotional materials, national and international pharmacovigilance regulations. Familiar with global regulations
Values and Competencies/Skills:
• Proven competencies such as influencing skills, clinical research insights, business, and market knowledge
• Able to manage and supervise people
• Good leadership, management and planning skills
• Medical and scientific writing skills
• State of the art knowledge of assigned therapeutic area and scientific expertise with ability to interact with relevant MEs as a peer
• Significant tolerance and ability to deliver under high ambiguity/uncertainty & complexity, resilience, ability to manage crisis & turnarounds.
• Results driven, focused and problem solving
• Effective communication/presentation skills with all management levels
• Ability to prioritize
• Strong collaborator, networking and relationship management
• Strong analytical and leadership skills (qualitative and quantitative aspects)
Languages: Russian, English fluent
Skills Desired
Clinical Protocols, Clinical Protocols, Cross-Functional Work, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communications, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategies, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies, Results-Oriented {+ 3 more}