Medical Lead
6 days ago
• In line with overall product strategy, the Medical Lead is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders.
About the Role
Major accountabilities:
Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions.
Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the respective therapeutic area.
Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities.
Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines.
Ensure medical insights are provided to cross functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others.
Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Key performance indicators:
Works within Ethics & Compliance policies - Achievement of annual targets for medical activities.
Minimum of 3 years of experience in medical affairs.
Proven experience in the local market.
Demonstrated expertise in pre-launch planning and execution.
Business proficiency in English.
Advanced degree (PhD or MD) in a relevant field is preferred.
Experience in renal therapy or related areas is preferred.
Novartis is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.
Functional Area:
Research & Development
Job Type:
Full time
Employment Type:
Regular
Shift Work:
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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