Career Options in the Pharmaceutical and Biomedical Industry: An Insider’s Guide

Description

Written by dedicated and active professionals from different areas of the pharmaceutical, biomedical, and medtech sectors, this book provides information on job and career opportunities in various life sciences industries. It also contains useful tips to launch your own startup. The pharmaceutical, biomedical and medical technology sectors offer a wide range of employment opportunities to talented and motivated young graduates. However, many of these employment prospects are not well known to early career scientists, who concentrate primarily on the scientific and academic content of their fields of interest. The book is divided into five parts: Part 1 provides an academic perspective that focuses on the specific preparation required in the final years of study to embark on a successful career in the pharmaceutical and biomedical industries. In Part 2, industry experts discuss employment possibilities all along the drug or product life cycle, from discovery research and development to commercialisation. Part 3 follows, highlighting opportunities in support functions such as regulatory affairs or quality assurance. Part 4 focuses on additional opportunities in the wider biomedical sector, while Part 5 contains practical tips and training opportunities for entering the pharmaceutical and biomedical industries. In the epilogue, the authors reflect on this fascinating field and its career prospects. The book offers a multidisciplinary perspective on career opportunities in the pharmaceutical and biomedical industry to a wide range of students and young life scientists. Preface Authors´ Professional Information Contents About the Editors Abbreviations Part I: Setting the Scene Chapter 1: Life After Academia: Launching Your Pharma/Biotech Career 1.1 Introduction 1.2 Timing, Skills and Strategy 1.3 Contextual Issues and Job Offers in the Pharmaceutical Sector 1.3.1 Academic Diversity in the Pharma and Biotech Sector 1.3.2 Science Parks and Hubs 1.3.3 Work Styles and Cultures 1.3.4 Rules and Regulations 1.3.5 Pharmaceutical Sector and Global Healthcare: New Perspectives 1.3.6 Visibility of the Best Vacancies 1.4 Closing Remarks Chapter 2: Competences for Pharmacists 2.1 The Traditional Competences of Pharmacists 2.2 The EU ``Pharmacy Education in Europe´´ Project for the Definition of Competences 2.2.1 Introduction 2.3 Methods 2.4 Results and Discussion 2.5 How to Use the Competence-Based Pharmacy Education (CBPE) Framework 2.6 Career Options Following the Evolution in Medicines 2.7 Career Options Following the Evolution in Responsibilities and Interaction with Others 2.8 Career Perspectives Following Evolution in Diagnosis 2.9 Evolution in Physical Interventions: The Example of Vaccination 2.10 Evolutions in Patient/Pharmaceutical Care 2.11 Evolution in Public/Private Financing, National/International Healthcare Policy and Economics 2.12 Career Options in Response to Global Change in the Environment, Climate and Illness 2.13 Conclusion Appendix The European Pharmacy Competence Framework (EPCF) References Chapter 3: Job and Career Opportunities in the Pharmaceutical Industry: An Overview 3.1 Introduction 3.2 The Pharmaceutical Industry 3.2.1 What Is Meant by the Pharmaceutical Industry? 3.2.2 Employment Potential 3.2.3 Place Within the Life Sciences Sector 3.3 The Drug Life Cycle 3.3.1 Drug Discovery Research 3.3.2 Drug Development 3.3.2.1 Functional Drug Development Disciplines 3.3.2.2 Drug Development Phases 3.3.3 Marketing Authorisation 3.3.4 Drug Commercialisation 3.3.4.1 Market Access 3.3.4.2 Marketing 3.3.4.3 Sales 3.3.4.4 Manufacturing 3.3.5 The End of the Drug Life Cycle 3.4 Operational Jobs Along the Drug Life Cycle 3.4.1 The Drug Project Team 3.4.2 Variety of Positions and Job Titles 3.4.3 Jobs in Drug Discovery and Design 3.4.3.1 Disciplines Involved 3.4.3.2 Required Qualifications and Skills 3.4.3.3 Workplace Setting 3.4.4 Jobs in Chemical/Pharmaceutical Development 3.4.4.1 Disciplines Involved 3.4.4.2 Required Qualifications and Skills 3.4.4.3 Workplace Setting 3.4.5 Jobs in Non-clinical Development 3.4.5.1 Disciplines Involved 3.4.5.2 Required Qualifications and Skills 3.4.5.3 Workplace Setting 3.4.6 Jobs in Clinical Development 3.4.6.1 Disciplines Involved 3.4.6.2 Required Qualifications and Skills 3.4.6.3 Workplace Setting 3.4.7 Jobs in Market Access 3.4.7.1 Disciplines Involved 3.4.7.2 Required Qualifications and Skills 3.4.7.3 Workplace Setting 3.4.8 Jobs in Medical Affairs 3.4.8.1 Disciplines Involved 3.4.8.2 Required Qualifications and Skills 3.4.8.3 Workplace Setting 3.4.9 Jobs in Marketing 3.4.9.1 Disciplines Involved 3.4.9.2 Required Qualifications and Skills 3.4.9.3 Workplace Setting 3.4.10 Jobs in Sales 3.4.10.1 Disciplines Involved 3.4.10.2 Required Qualifications and Skills 3.4.10.3 Workplace Setting 3.4.11 Jobs in Manufacturing 3.4.11.1 Disciplines Involved 3.4.11.2 Required Qualifications and Skills 3.4.11.3 Workplace Setting 3.5 Jobs in Overarching Supportive Functions 3.5.1 Jobs in Regulatory Affairs/Science(s) 3.5.1.1 Essential Functions 3.5.1.2 Preferred Qualifications and Skills 3.5.2 Jobs in Quality Management 3.5.2.1 Essential Functions 3.5.2.2 Preferred Qualifications and Skills 3.5.3 Jobs in Pharmacovigilance 3.5.3.1 Essential Functions 3.5.3.2 Preferred Qualifications and Skills 3.5.4 Jobs in Medical/Scientific Writing 3.5.4.1 Essential Functions 3.5.4.2 Preferred Qualifications and Skills 3.5.5 Jobs in Project Planning 3.5.5.1 Essential Functions 3.5.5.2 Preferred Qualifications and Skills 3.6 Jobs in Other Essential Business Roles 3.6.1 Business Intelligence 3.6.2 Portfolio Management 3.6.3 Business Development 3.6.4 Human Resources 3.6.5 Training and Development 3.6.6 Information Technology 3.6.7 Finance and Accounting 3.6.8 Legal Affairs 3.7 How to Kick-Start Your Career in This Sector? 3.7.1 Wanted Qualifications 3.7.1.1 Graduates in Life Sciences 3.7.1.2 Other Sought Disciplines 3.7.1.3 All Levels of Higher Education Have a Chance 3.7.2 Key Employability Assets 3.7.2.1 Know What You Want 3.7.2.2 Soft Skills 3.7.2.3 What About Professional Experience? 3.7.3 Some Practical Advice 3.8 Career Perspectives 3.8.1 General Introductory Concepts 3.8.1.1 Career Development Approaches 3.8.1.2 How (Pharmaceutical) Companies Are Organised 3.8.1.3 Management Levels 3.8.2 Career Management 3.8.2.1 Career Planning 3.8.2.2 Career Development 3.8.3 Career Opportunities 3.8.3.1 Career Progression Modalities in General 3.8.3.2 Career Opportunities in the (Bio)Pharmaceutical Industry 3.8.3.3 Career Opportunities in the Wider Life Sciences Sector 3.9 Conclusion References Part II: Opportunities Along the Drug/Product Life Cycle Chapter 4: Career Opportunities in Toxicology 4.1 Introduction 4.2 Basic Skills Required for a Career in Toxicology 4.3 Career Profiles of Toxicologists in Academia 4.4 Career Profiles of Toxicologists in Pharmaceutical Industry 4.5 Career Profiles of Toxicologists in Industries Other than Pharmaceutical Industry 4.6 Career Profiles of Toxicologists in Regulatory Organisations 4.7 Career Profiles of Toxicologists in Contract Research Organisations 4.8 Career Profiles of Toxicologists in Consulting Companies 4.9 Certification 4.10 Conclusion References Chapter 5: Job Possibilities in Clinical Research 5.1 Introduction 5.2 Life Cycle of a Clinical Trial 5.3 Job Opportunities in Clinical Research 5.3.1 Positions in Investigational Sites 5.3.2 Positions in Ethics Committees and Regulatory Authorities 5.3.3 Positions in the Industry 5.4 Clinical Research in a Pharma Company Versus in a CRO 5.4.1 Types of Outsourcing 5.4.2 Job Opportunities in a CRO 5.5 Career Development in Clinical Research 5.5.1 Required Background 5.5.2 Clinical Research Competencies 5.5.3 Ongoing Training and Development 5.5.4 Where to Look for Vacancies? 5.6 Conclusion References Chapter 6: How to Get and Develop a Career in a Market Access Role in the Medical Devices´ Industry 6.1 Introduction 6.2 The Healthcare Market: A Brief Overview 6.3 The Key Stakeholders a Market Access Professional Should Engage 6.4 The Challenge of Value Demonstration 6.5 The Key Skills and Competences for Getting an Opportunity in a Market Access Role and Its Career Development 6.6 How to Effectively Get a Job Opportunity in a Market Access Position 6.7 Conclusions Bibliography Chapter 7: Job Opportunities in Pharmaceutical Marketing 7.1 The Importance of Commercialising a Medicine 7.2 What Is Pharmaceutical Marketing? 7.2.1 Insights, Insights, Insights 7.2.2 Thinking Strategy 7.2.3 Designing and Developing Omnichannel Campaigns 7.2.4 Drug Promotion Regulation 7.2.5 A Full Range of Tasks 7.3 Qualifications and Skills 7.4 Career Opportunities 7.5 Conclusion Chapter 8: Working in Medical Affairs and Clinical Operations: Life-Changing Careers 8.1 Research and Development 8.2 The Roles of Medical Affairs and Clinical Operations in the Constantly Evolving Scientific and Health Scenario 8.2.1 Medical Affairs 8.2.2 Clinical Operations 8.2.3 Regulatory and Safety 8.2.4 Life-Changing Careers 8.2.5 Conclusion References Chapter 9: The Role of Medical Science Liaison 9.1 Introduction 9.2 How Do I Become a Medical Science Liaison? 9.3 Who Are the Stakeholders? 9.4 What Are the Activities Carried Out by the Medical Science Liaison? 9.5 Planning of MSL Activities 9.6 Hard and Soft Skills Required 9.7 Future Perspective 9.8 Conclusion References Chapter 10: Career Development for Physicians in the Biopharmaceutical Industry 10.1 Introduction 10.2 Why Would a Physician Choose a Career Within the Pharmaceutical Industry? 10.3 What to Expect as a Physician Working in the Pharmaceutical Industry? 10.4 When Do I Take the Step and What Do I Need? 10.5 How Do I Develop My Career, and What Are Key Factors for Success? 10.5.1 You Drive Your Career Development 10.5.2 CMO Model 10.5.2.1 Competences or Skills 10.5.2.2 Motivation 10.5.2.3 Opportunities 10.5.2.4 70-20-10 Model 10.6 Conclusion References Part III: Opportunities in Supportive Functions Chapter 11: Job and Career Opportunities in Regulatory Affairs/Science 11.1 Regulatory Science Versus Regulatory Affairs 11.2 Regulatory Functions Within the Pharmaceutical Industry 11.2.1 The Purpose of Regulatory Affairs 11.2.2 The International Context 11.2.3 Roles and Responsibilities of Regulatory Affairs Professionals 11.2.4 Job Opportunities 11.3 Regulatory Functions Within Regulatory Authorities 11.4 Requirements for a Successful Career in Regulatory Affairs 11.4.1 Qualifications 11.4.2 Skills 11.4.3 Experience 11.5 Career Perspectives 11.6 Conclusion References Chapter 12: Job Opportunities in Clinical Research Quality Assurance 12.1 Introduction 12.2 What Is ICH GCP? 12.3 Quality, Quality Management, and Quality Assurance 12.3.1 Quality Assurance 12.3.2 Government and Ethics Committees 12.3.3 Organization of Quality Management in Clinical Research 12.3.4 Keeping Up with Developments 12.3.5 General Consideration on Quality Management 12.3.6 Challenges in Quality Management 12.4 Quality Assurance Roles and Career Options 12.4.1 Roles 12.4.2 Educational Background and Personal Disposition 12.4.3 How to Start and Develop a Career in Quality Assurance Appendices Appendix 1: Topics in ICH GCP Appendix 2: Definitions Some References and Further Reading Chapter 13: Job Opportunities in Quality Assurance Related to Manufacturing of Medicinal Products 13.1 Introduction 13.2 Manufacturing of a Medicinal Product 13.3 The Regulatory Environment 13.3.1 Directives and the EudraLex in Europe 13.3.2 Title 21 CFR in the United States 13.3.3 The ICH 13.4 The Quality Management System 13.4.1 The Pharmaceutical Quality System 13.4.2 Personnel 13.4.3 Premises and Equipment 13.4.4 Documentation 13.4.5 Production 13.4.6 Quality Control 13.4.7 Outsourced Activities 13.4.8 Complaints and Product Recalls 13.4.9 Self-Inspection 13.5 The Quality Unit 13.5.1 The Quality Head 13.5.2 Quality Systems 13.5.3 Quality Operations 13.5.4 The Qualified Person 13.5.5 Quality Control 13.5.6 Compliance 13.5.7 Qualification and Validation 13.5.8 Regulatory Affairs 13.6 Qualifications and Skills 13.7 Career Perspectives 13.7.1 Evolving Within the Quality Organization on Site 13.7.2 From Manufacturing to Quality and Vice Versa 13.7.3 Transferring from One Environment to Another 13.7.4 Global Roles for Quality Assurance 13.7.5 Working for Regulatory Authorities/Agencies/Health Institutions 13.8 Conclusion References Part IV: Other Opportunities in the Pharmaceutical and Biomedical Sector Chapter 14: Careers´ Perspective in a Science and Technological Park 14.1 Brief Introduction on Science and Technology Parks 14.1.1 Technology Park for Medicine (TPM) ``Mario Veronesi´´: An Example of a Science and Technology Park 14.2 Medical Device Sector 14.3 Job Opportunities in Science and Technology Parks 14.3.1 High-Tech Profile 14.3.2 Services Profile 14.3.3 Regulatory Specialist and Quality Manager 14.3.4 Communication and Marketing 14.3.5 Technology Transfer and Project Manager 14.3.6 Career Perspectives 14.4 Conclusion References Chapter 15: To Be or Not to Be: Entrepreneurship and Enterprise Creation as a Way to Innovate in Life Sciences 15.1 Entrepreneurship as a Key Skill and Opportunity for Potential Innovators in Life Sciences 15.2 Impact of Entrepreneurship and Entrepreneurs in Life Sciences on Our Society 15.3 From Science to Innovation: The Alternative Way Through Start-Up Creation 15.3.1 The Path from Science to Start-Up Growth 15.3.2 Key Roles Inside a Start-Up for Scientists 15.4 Training on Entrepreneurship and Life Sciences: From Hidden Gems to Standard Curricula 15.5 Conclusions, Suggestions and Future Perspectives: A Way Forward, Unlocking the Potential of Entrepreneurial Education References Chapter 16: How to Become a Successful Hospital and Community Pharmacist 16.1 Introduction 16.2 Transformation of Hospital Pharmacy Practice 16.2.1 Quality Standards 16.2.2 Dispensing and Administration 16.2.3 Medication Monitoring Activities 16.2.4 Medication Use 16.2.5 Domains of Hospital Pharmacy Practice 16.3 Transition of Care 16.3.1 Domains of Transition of Care 16.4 Community Pharmacy Practice 16.4.1 Patient Empowerment 16.4.2 Preventive Medicine 16.4.3 Coordination of Care 16.5 Patient-Centric Hospital and Community Pharmacy Practice 16.6 Measurement of Success 16.7 Pathways to Success 16.8 Career Opportunities in Hospital and Community Pharmacy Practice 16.9 Conclusion and Future Perspectives References Part V: Practical Tips and Tricks Chapter 17: A Successful Career in the Life Sciences Industry: How to Write Your Strongest Resumé and Ace that Interview 17.1 The Academic Paradox! 17.2 Understand Who You Are 17.2.1 Ask Your Community: Who Am I? 17.3 Write that Personal Resumé 17.3.1 How to Reach You 17.3.2 What Do You Want? 17.3.3 Your Professional Experience 17.3.4 Your Education/Academic Background/Scholarships and Grants 17.3.5 Language/IT Competences 17.3.6 Publications 17.4 Ace That Interview 17.4.1 Come Prepared to the Interview 17.4.1.1 Appearance Is Key 17.4.2 What Type of Questions to Expect and What Questions to Ask? 17.4.3 Follow Up on the Interview 17.5 Be Authentic Chapter 18: Skill Building for Career Advancement: Public Speaking and Networking 18.1 Introduction 18.2 Importance of Public Speaking 18.3 Skills and Advice for Public Speaking and Communication 18.4 Importance of Networking 18.5 Final Thoughts References Chapter 19: Training Opportunities for a Career in the Pharmaceutical and Biomedical Industry 19.1 Introduction 19.2 Education and Training Offered by Academia 19.2.1 Targeted Graduate Master Programmes 19.2.2 Postgraduate or Advanced Master Programmes 19.2.3 More Focused Training Opportunities 19.2.4 Broader Additional Training Opportunities 19.2.5 Inter-University and International Initiatives 19.3 Training Offered by the Pharmaceutical and Biomedical Industry 19.4 Training Offered by Other Organisations 19.4.1 University Spin-Offs 19.4.2 Public-Private Partnerships (PPPs) 19.4.3 Regulatory Authorities 19.4.4 Professional Organisations 19.4.5 Other Non-profit Organisations 19.4.6 Private Service Providers 19.5 Conclusion Useful Websites QR-Codes for the Above Collection of Useful Websites Epilogue