Evidence Generation Manager

hace 4 semanas

Bogotá, Bogotá D.E., Colombia Novartis A tiempo completo
Job Description Summary

Provides RWE expertise, effective project management skills and oversight to ensure successful delivery of innovative and scientifically robust evidence to secure, maintain and grow access for patients to Novartis innovative therapies. Oversees and manages evidence generation activities in close collaboration with the Medical Leads and MSLs. Provides highly advanced expert support, functional and technical guidance to ensure the scientific integrity/validity for clinical development, early development, and/or research projects.

Job Description

Major accountabilities

1. Evidence Generation: To support the coordination, development, and implementation of innovative integrated evidence plans. To provide expertise on evidence generation methodology and innovative approaches. To identify opportunities for evidence generation aligned with medical and brand priorities, through other cross-functional activities including digital engagement. To anticipate and evaluate future needs and trends for RWE information within specified health care environments.
2. RWE Study Development, Execution and Oversight: Gather and cross-functionally share relevant insights in the framework of the evidence integrated plans development (advisory boards, scientific trends etc), to leverage the local RWE opportunities. Accountable for RWE integrated evidence plans for priority TAs, in close collaboration with Medical Leads, as well as Market Access, to meet increasing external RWE demands from payers, HCPs, policymakers and patients. Accountable for RWE projects' timely delivery and study management, including development of concept sheets for global approvals, protocols, external approvals, study report/publication and scientific disclosure. Leading and/or contributing with technical expertise and research methodological understanding for observational/epidemiologic research, ensuring projects are conducted in line with legal and compliance framework.
3. Strategic and Business Mindset: Patient and customer-centric thinking in co-creating impactful integrated evidence plans with understanding of business and client needs, in line with the local CPO priorities. Support target patient population outcomes as a metric of medical impact. Broad understanding of across all disease areas and drug development. Building and managing strategic partnership with HCO/Third Party Organization to access external data source/analysis, ensuring information governance and data protection. Maintain understanding and engagement with local health data and research landscape.
4. Leadership & Culture: Ensure and drive cross-enterprise capability building in the area of expertise. Lead the development of effective evidence generation team building through enterprise mindset & cross-functional excellence. Effectively operate in cross-functional teams, including early launch, BE&E (data & insights). Role model for our culture, values & behaviors, consistently demonstrating the highest ethics and integrity-based standards. Demonstrate enterprise perspective and delivery of medical evidence to address priority business challenges.
5. Other: Track deviations and support implementation/resolution of local CAPA plans. Follow up/support to audits and self-assessments processes.

Ideal Background

1. Languages: English
2. Experience in Clinical Research Phases
3. Clinical Trial Design, Data Review & Reporting
4. Collaborating across boundaries
5. Critical Negotiations
6. Financial Management
7. Operations Management and Execution

Competencies

1. Breakthrough Analysis
2. Digital & Technology Savvy

Benefits and rewards

Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Benefits and Rewards

Commitment 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.

Skills Desired

1. Budget Management
2. Clinical Trials
3. Negotiation Skills
4. Process Improvement
5. Project Planning
6. Vendor Management
7. Waterfall Model

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