Job Description

Summary 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 stakeholdersMajor 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 Requirements:
Work Experience:

• 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

• Collaborating across boundaries

• Operations Management and Execution

• Project Management

Youll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.Commitment to Diversity and Inclusion:Novartis is an Equal Opportunity Employer and take 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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.Skills Desired Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, , Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)

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