Randy Bowen MD MBA

Experience

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  Pacífica Salud

  Jun 2010 - May 2012

  Hospitalist Physician

  I was in charge of the caring of patients during their hospital stay on night shifts. I was available to answer any questions that the patient or family members may have about their health or about hospital services.I was part of the hospital team that was essential for the recent accreditation of this hospital by the JCI ( Joint Commission International). I worked closely with the patient's Primary Care Physician, specialists and hospital staff to coordinate medical services specific to their needs. Show less

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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  May 2012 - Sept 2015

  Medical Manager - Virology, CNS, Cardiovascular & Metabolism

  As a certified Medical Physician by the Educational Commission for Foreign Medical Graduates (ECFMG) in the United States, in my role as Medical Manager, I was in charge of the sales force training of our region (Venezuela, Central America and the Caribbean ), planning and coordination of local and international continuous medical education events following compliance processes of the company, development and revision of educational materials for physicians, patients and sales force on products, management of budgets for educational events, development of product strategies and Medical Plans for the products aligned with marketing, supervision and execution of clinical studies. I collaborated with Regulatory Affairs & Pharmacovigilance to forward any safety-related inquiry or relevant communication (Core Additional Risk Minimization Activities) and review of Pharmacovigilance plans, Risk Minimization Measures and cRMP summaries.I was the leader of the development of the sales force training methodology for all franchises in our cluster in the company for 2012 and 2013 for which I received an Silver Encore Award by the Company. I was the leader of our main medical educational and pharmacoeconomic event in 2014 for all the franchises and countries where we gathered in one event, physicians and other health professionals from different specialties.I was awarded with a Platinum Encore Award by the company for my Leadership in our 2014 CME Summit. I have launched with the commercial team products like Incivo (for hepatitis C), and recently Invokana for type 2 diabetes in Venezuela, Central America and the Caribbean. I participated as speaker in the most important Massive Media in Guatemala and Panama educating on Disease Awareness and Innovative Therapies for Type 2 Diabetes. I supported the Marketing Team as Product Manager for Hep C portfolio and was in charge developing the Marketing Brand Plan for Hepatitis C for 2016 as a project for my professional development. Show less

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  Roche

  Jan 2016 - Oct 2017

  Centralized Solutions Product Manager for Central America & The Caribbean

  - Responsible for planning, implementing, and monitoring the marketing activities of Serum Work Area (Immunology IMM & Clinical Chemistry CC) including Specialty Testing (HEM, COAG, UR) Solutions with increased emphasis on Reagents and Instruments launches for Central America &The Caribbean. - Manage Product Portfolio of Serum Work Area & Specialty testing Solutions for the cluster emphasizing on testing efficiency strategy and complementing with the Medical Value strategic approach. - Plan and execute Business Plans with effective tactics and actions aligned with Medical Affairs & Market Access.- Plan and coordinate new product launches on a regional perspective. - Instruments & Reagents Portfolio lifecycle management within the cluster. - Follow guidelines and implement initiatives from the Latam CS Working Group Cross functional members and Projects. - Guarantee that sales personnel have the adequate understanding of the product concept & strategy, product training and marketing tools to support its daily work. - Monitoring of market trends, customer needs and developments in the medical/diagnostic area. Transfer of the findings into proposals for strategies to further develop the CA&C market. - Responsible for the establishment of promotional material, reviews and providing input according to global branding guidelines. - Initiate and establish successful partnerships with non -Roche companies according to Roche global compliance policies. Show less

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  Sanofi

  Dec 2019 - now

  The Global Partner Markets Team Lead serves as the Medical & Regulatory Affairs Director, overseeing a global network of countries operating under a Distributor Model. This role leads a team of Medical & Regulatory Leads, ensuring regulatory and medical activity execution, compliance & governance along with strategic alignment and cross-functional collaboration to support product commercialization and compliance.Key Responsibilities:Regulatory Strategy & Compliance• Lead regulatory intelligence efforts to monitor global regulatory trends and ensure business alignment.• Develop and execute regulatory strategies to support product registration, commercialization, and lifecycle management.• Ensure compliance with global and local regulations, managing risk assessments and mitigation plans.Regulatory Operations & Partner Oversight• Supervise regulatory submissions, renewals, and compliance monitoring across distributor markets.• Provide strategic oversight to Distributors, MAHs, and local agents, ensuring regulatory obligations are met.• Manage regulatory databases and documentation systems (e.g., Veeva RIM, Veeva PromoMAT, VISTAlink).Medical Affairs, Governance & Partner Oversight• Oversee medical governance frameworks and ensure adherence to corporate policies and ethical standards.• Manage medical information inquiries and medical risk assessments, ensuring scientific accuracy and compliance.• Lead training initiatives to ensure internal and external stakeholders align with medical and regulatory requirements.• Supervise medical activities across distributor marketsCross-functional Leadership & External Relations• Act as a liaison between regulatory, medical, and commercial teams to drive alignment and execution.• Manage relationships with regulatory agencies, industry bodies, and business partners.• Oversee compliance with contractual and regulatory requirements across distributor networks. Show less -Act as a liaison between Global Functions within Science Hub, Global Quality, Regional Governance Team and Commercial Operations departments when applicable to ensure the implementation of medical & regulatory governance guiding principles and processes in compliance with laws, regulations and company quality standards-Define, structure, and implement global governance frameworks for GxP & Health-Regulated activities within Scientific Affairs and more particularly for Medical & Regulatory, in accordance with applicable regulations, company quality standards and the defined GxP Quality System.-Provide strategic, harmonized, and operational guidance for GxP and health-regulated activities part of Scientific Affairs, in coordination with the Region Governance & Excellence Team & the other Quality & Governance Team members (Medical Quality Lead & RA Quality Lead)-Work with Ethics & Business Integrity (EBI) & Internal Control to provide strategic and operational guidance for compliance to support Scientific Affairs activities in compliance and adherence to the Sanofi Code of Ethics-Responsible to collect any findings (from Audits & Inspections) and areas for improvement, simplification, training, or other significant topics from the Region Governance & Excellence Team & the other Quality & Governance Team members (Medical Quality Lead & RA Quality Lead), lead the reporting to global functions, make recommendations-Leading and managing cross functional projects/initiatives where regulatory and medical activities are involved in the purpose of compliance and governance- Ensure development and early adoption of global initiatives across all Regions, in compliance with company standards and processes Show less -Co-create high-quality plans for the medical brand planning cycle and ensure execution of the CHC Regional Medical Strategy in line with the local/global Strategy-Structure operational Regional CHC Medical Leadership Team meetings -Provide the overview over medical strategies implementation in the region and to track performance-Co-manage and track Medical budget within the region assessing investment on local clinical trials and medical programs for the brands, assessing and scaling for wider scope in the region.-Assist with the management of projects through governance and approval and present regular project/portfolio/budget status updates to management-Coordinate & ensure execution of clinical and medical projects according to budget, timelines and quality standards-Develop tools and processes for best practice sharing within the team and cross functionally Show less -Ensures the execution of the CHC Regional Medical strategy by working closely with the Regional Head of CHC Medical, set out clear operational priorities for teams, and ensure local/global alignment on where, and how, value should be created by the CHC Medical organization.-As a senior representative for the region in the Global CHC Medical Operations & Governance team, align on the strategic medical brand planning cycle deployment, ensure local development of high-quality medical plans with aligned KPIs. -Ensure efficient coordination & execution of clinical projects in a way that maximally leverages local/global efforts. Localize approaches to ensure impact in key geographies.-Lead budget review cycles, including the consolidation, alignment, and monitoring of regional medical budget.-Promote science inspired innovation ideation, creation & execution in priority markets.-Ensure the required deployment of governance, processes and capability building initiatives.-Understand & track regional/global performance metrics and ensure compliance on critical KPIs.- Assist with the interpretation and development of regional alignment to global CHC Medical strategic direction (where appropriate) & allocate resources to prioritized opportunities-Understand, interpret & communicate operational priorities to key internal stakeholders in the Regional CHC GBU and broader One-Medical organization-Promote a transversal culture that is consumer focused & driven to achieve innovation-Implement and facilitate regular operational exchange meeting within their region and build alignment across internal stakeholders on priorities & approaches Show less -Evaluate & define a portfolio approach for Medical value creation across COPAC teams, ensuring clear priorities are defined at a local level for all CHC Medical team members.-Manage COPAC medical team(s) creating an environment for professional growth of team members.-Actively shape the regional or local business direction through input into the zone or local CHC Leadership Team.-Promote scientific innovation opportunities across our portfolio through proactive cross-functional working of team members in contributing to global strategic medical brand plans and the development of local medical affairs plans.-Proposal and execution of key activities which include insight generation / anticipating trends, science inspired innovation opportunities (claim enhancement, product development, life cycle management, medical evaluation of BD opportunities, local switch opportunities), scientific endorsement & stakeholder management, risk mitigation.-Drive delivery of medical commitments by the execution of the medical affairs plans at a local level with clearly defined KPIs towards the desired outcome(s) -Ensure appropriate representation & collaboration by local Medical teams within Extended Global Category Medical Teams.-Ensure CHC Medical governance/compliance is implemented and ensure company/industry standards are maintained at all times Show less

  • Global Partner Markets Team Lead LATAM

    Nov 2023 - now

  • Global Governance Lead - Scientific Affairs

    Sept 2021 - Nov 2023

  • Regional CHC Medical Portfolio Manager North America (Interim)

    Aug 2020 - Sept 2021

  • Regional CHC Medical Portfolio Manager LATAM

    Nov 2017 - Sept 2021

  • Interim CHC COPAC Medical Head

    Dec 2019 - Mar 2020