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Medical Project Lead Gene Therapies
hace 2 semanas
Summary: Location: LimaAbout the role: The Medical Project Lead will lead the design, implementation and execution of Medical Affairs plans for Gene Therapies, providing scientific information, helping design & prioritize clinical studies, building educational dialogue with KOLs and regulatory partners.Key Responsibilities:Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish response documents 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 partner 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 internal controls within the area of responsibilities.Essential Requirements:University degree in life science is mandatory, physician (MD) is highly desirable.Validated experience in access and/or medical roles within the pharmaceutical industry, preferably working with rare diseases.Partner engagement.Proficient in English & Spanish.Cross-functional collaboration and leadership.Strategic mindset / agile learning.Availability to do up to 30% of field work.Benefits and rewardsCommitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Division: InternationalBusiness Unit: Innovative MedicinesLocation: PeruSite: Lima (Pharmaceuticals / GDD / CTS)Company / Legal Entity: PE01 (FCRS = PE001) Novartis Biosciences PeruFunctional Area: Research & DevelopmentJob Type: Full timeEmployment Type: RegularShift Work: No
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