Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Michelle Trespach

Fort Lauderdale,FL

Summary

Experience Medical Affairs Vice-President with a demonstrated history of working in the pharmaceuticals industry. Skilled in Clinical Research, Pharmacovigilance, Regulatory, Scientific and Medical Affairs. Passionate about applying excellent organization and communication skills to manage and lead teams. Results-oriented individual well-versed in interfacing and consulting on business processes to drive results based on sound overall business judgment.

Medical Degree - Health Care Professional graduated from PUCRS - Brazil. Pulmonologist, with a MBA performed at the School of Business Administration at the University of Miami.

Overview

24
24
years of professional experience
1
1
Certification

Work History

Vice President Medical Affairs Latin America

Johnson & Johnson
07.2021 - Current
  • Develop and deliver regional Medical Affairs (MAF) strategic objectives and plans, ensuring adequate resourcing, in alignment with patient needs, business priorities and company strategy to be transformational medical innovator.
  • Led cross-functional teams for successful completion of major projects, resulting in increased efficiency and customer impact.
  • Identify growth opportunities and forging strategic partnerships with key healthcare stakeholders, including customers, vendors, regulators, and medical community leaders to promote collaboration and long-term success.
  • Established a culture of continuous improvement, fostering innovation and driving sustainable growth across organization while optimizing operational processes.
  • Championed talent development programs, promoting employee engagement and retention while enhancing overall workforce capabilities.

Scientific Affairs Sr Director LATAM

Janssen Inc.
01.2019 - 06.2021

Leadership and strategic guidance of the Scientific Affairs Area, including Customer Services Contact center, MedInfo, Scientific Content Management and Development, Evidence Generation & Publication Strategy, Scientific Data Analysis and Insights, Medical Affairs Compliance, Pharmacovigilance operations, Customer Engagement and Continued Medical Education (CME).

Management of a team of 60 employees, overseeing hiring, training, and professional growth of employees. Responsive and proactive in building capabilities to create a diverse high performing medical organization.

Ensure integration and synergy among Local operating companies and regional and Global strategies.

Used critical thinking to break down problems, evaluate solutions and make decisions. Actively listened to customers' requests, confirming full understanding before addressing concerns.

Medical Affairs and Regulatory Director Mexico

Janssen Inc.
07.2016 - 12.2018

Responsible for the leadership and guidance of a MAF team with more than 35 people, to enhance both regulatory and medical affairs capabilities. Turning over both pharmacovigilance and regulatory affairs to a strategic approach. Ensuring a positive impact at field with a consolidated and aligned MSLs group and positioning medical affairs as a business partner.

Respiratory Medical Director LatinAmerica & Canada

Novartis
05.2012 - 06.2016

Medical Director for the Respiratory Franchise for Latin America and Canada responsible for developing and implementing the strategic medical direction for the key products and answers medically based questions concerning medical, legal, Pharmacovigilance and regulatory matters. Ability to act as an interlocutor between the scientific field and the business, driving business through the ethic with patient centricity, supported by a solid scientific knowledge and a broad marketing view. Recognized as a highly innovative person with a high rate of an innovative success prized projects with customer´s focus and business drive, with excellent vision of business and market needs.

Clinical Research Country Head Mexico

Novartis
07.2009 - 04.2012

In charge of developing the trial strategic execution plan, control and managing clinical studies, logistics and personnel in a multicultural environment and leading a diverse team.

International experience in Research and Development in therapeutic areas such as: Immunology, Neuroscience, Respiratory, gastroenterology and cardiology including pediatric trials.

Deep knowledge of GCP guidelines, local and global standards, procedures and quality controls for monitoring clinical studies.

Latin America Respiratory Medical Manager

Novartis
11.2007 - 06.2009

Regional Medical Expert for Respiratory Area, including asthma, COPD and Cystic Fibrosis products.

Clinical Study Manager

Novartis
02.2006 - 11.2007

Manager responsible for clinical trials of Respiratory Area for Argentina, Chile and Uruguay (South Cluster) and in charge of a team of 12 Clinical Research Associates (CRAs).

Research Project Leader

Novartis
04.2005 - 01.2006

Project lead for Respiratory, Dermatology and Infectology trials in Argentina.

Clinical Research Associate

Novartis
08.2003 - 03.2005

Monitoring of several clinical trials, responsible for different phases of the process, from site feasibility/selection up to close out activities.

Co-Investigator

Dr. Enrique Tornú Hospital
08.2001 - 08.2003

Co-Investigator of Phase II-III respiratory trials (during Respiratory Specialization).

Medical Practice

ECCO-SALVA
12.1999 - 03.2000

Medical Emergency Services - general physician practice.

Medical Practice

Centro Médico ITAPEMA S.A.
11.1999 - 03.2000

Medical Office - general physician practice.

Education

MBA - Business Administration And Management

University Of Miami
Florida - USA
12-2012

Bachelor of Business - Business Education

Universidad Di Tella
Buenos Aires - Argentina
11-2008

Pulmonologist - Pulmonary Specialization

Dr. Enrique Tornú Hospital
Buenos Aires - Argentina
12-2003

Internal Medicine - Fellowship

Anchorena Hospital
Buenos Aires - Argentina
12-2001

M.D. - Medical Doctor

Pontificia Universidade Catolica (PUCRS)
Porto Alegre - Brazil
11-1999

Skills

  • Strategic and Critical Thinking
  • Business Acumen
  • Leadership
  • Risk Management
  • Operations Management
  • Assertive Communication

Certification

  • Johnson & Johnson’s Talent Acceleration Program
  • Johnson & Johnson’s Enterprise Sponsorship Program
  • LEADERS DEVELOPING LEADERS Program (LDL)
  • Leading Global Projects Program
  • ADVANCED COURSE: THE SCIENCE OF COPD, OPPORTUNITIES FOR IMPROVING PATIENT CARE
  • NEGOTIATION EXCELLENCE PROGRAM (NEP)
  • LEADERSHIP PROGRAM
  • HR FOR NON HR MANAGERS
  • MARKETING PROGRAM – FUNDAMENTAL CONCEPTS
  • TALLER DE ADMINISTRACIÓN DE PERSONAL
  • TALLER DE RESPONSABILIDAD SOCIAL EMPRESARIA
  • TALLER DE ÉTICA EN LOS NÉGOCIOS
  • Good Clinical Practice (GCP) Certification
  • CURSO DE MEDICINA BASADA EN LA EVIDENCIA
  • ACTUALIZACIONES EN INVESTIGACIÓN CLÍNICA
  • Curso de Regulaciones en Investigación Clínica
  • CRA COMPLIANCE TRAINING (ICH-GCPs and SOPs)
  • CURSO DE ENTRENAMIENTO DE FUNCION PULMONAR PDSR CPL

Languages

English
Full Professional
Spanish
Native or Bilingual
Portuguese
Native or Bilingual

Timeline

Vice President Medical Affairs Latin America

Johnson & Johnson
07.2021 - Current

Scientific Affairs Sr Director LATAM

Janssen Inc.
01.2019 - 06.2021

Medical Affairs and Regulatory Director Mexico

Janssen Inc.
07.2016 - 12.2018

Respiratory Medical Director LatinAmerica & Canada

Novartis
05.2012 - 06.2016

Clinical Research Country Head Mexico

Novartis
07.2009 - 04.2012

Latin America Respiratory Medical Manager

Novartis
11.2007 - 06.2009

Clinical Study Manager

Novartis
02.2006 - 11.2007

Research Project Leader

Novartis
04.2005 - 01.2006

Clinical Research Associate

Novartis
08.2003 - 03.2005

Co-Investigator

Dr. Enrique Tornú Hospital
08.2001 - 08.2003

Medical Practice

ECCO-SALVA
12.1999 - 03.2000

Medical Practice

Centro Médico ITAPEMA S.A.
11.1999 - 03.2000

MBA - Business Administration And Management

University Of Miami

Bachelor of Business - Business Education

Universidad Di Tella

Pulmonologist - Pulmonary Specialization

Dr. Enrique Tornú Hospital

Internal Medicine - Fellowship

Anchorena Hospital

M.D. - Medical Doctor

Pontificia Universidade Catolica (PUCRS)
Michelle Trespach