Medical Manager
hace 1 semana
-In line with overall product strategy, the Medical Advisor 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 RoleMajor 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 -Distribution of marketing samples (where applicable)
Key performance indicators:
- Works within Ethics & Compliance policies -Achievement of annual targets for medical activities
- Operations Management and Execution.
- Project Management.
Skills:
- Building Construction.
- Clinical Practices.
- Clinical Research.
- Clinical Trials.
- Drug Development.
- Health Sciences.
- Intensive Care UnIT (Icu).
- Internal Control.
- Internal Medicine.
- Job Description.
- Medical Information.
- Organization Skills.
- Stakeholder Engagement.
- Tcp/Ip Protocols.
Languages :
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. Ready to create a brighter future together?
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Division International
Business Unit Pharmaceuticals
Location Mexico
Site INSURGENTES
Company / Legal Entity MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
Accessibility and accommodationNovartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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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