Careers with the Pharmaceutical Industry Second Edition CareerswiththePharmaceuticalIndustry,Secondedition.EditedbyP.D.Stonier. &2003JohnW|ley&SonsLtd.ISBN0470843284 Careers with the Pharmaceutical Industry Second Edition Edited by Peter D. 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Previoused.publishedwithtitle:Discoveringnewmedicines. Includesbibliographicalreferencesandindex. ISBN0-470-84328-4(alk.paper) 1.Pharmacy–Vocationalguidance.2.Pharmacy–Research–Vocationalguidance.3. Pharmaceuticalindustry–Vocationalguidance.4.Pharmaceuticalchemistry–Vocational guidance.I.Stonier,P.D.II.Discoveringnewmedicines. RS122.5.D572003 6150.1900023–dc21 2003041094 BritishLibraryCataloguinginPublicationData AcataloguerecordforthisbookisavailablefromtheBritishLibrary ISBN0470843284 TypesetbyDobbieTypesettingLtd,Tavistock,Devon PrintedandboundinGreatBritainbyBiddlesLtd,Guildford,Surrey Thisbookisprintedonacid-freepaperresponsiblymanufacturedfromsustainableforestry inwhichatleasttwotreesareplantedforeachoneusedforpaperproduction. Contents List of Contributors ix Preface xiii Preface to the First Edition xv Acknowledgements xvii I Background to Medicines Research and Development 1 1 Pharmaceutical Medicine—A Specialist Discipline 3 Felicity Gabbay 2 The Contribution of Academic Clinical Pharmacology to Medicines Research 17 Charles F. George 3 A Career in Drug Discovery 29 David Ellis II Careers in Pre-Clinical and Clinical Research 45 4 A Career in Clinical Pharmacology 47 Roger Yates 5 Career Opportunities for Physicians in the Pharmaceutical Industry 55 Bert Spilker 6 The Clinical Research Associate 67 Gareth Hayes CareerswiththePharmaceuticalIndustry,Secondedition.EditedbyP.D.Stonier. &2003JohnW|ley&SonsLtd.ISBN0470843284 vi CONTENTS 7 Clinical Trial Administrator and Study Site Co-ordinator— Key Roles in Clinical Research 79 Nicola Murgatroyd, Caroline Crockatt and Gareth Hayes 8 Statisticians in the Pharmaceutical Industry 99 Christopher Hilton and Trevor Lewis 9 Careers in Data Management 111 Sheila Varley 10 Working in a Contract Research Organisation 119 Jane Barrett III Careers in Sales and Marketing 127 11 A Career in Product Management 129 Roy Carlisle 12 A Career in Medical Sales and Medical Sales Management 137 Roy Carlisle IV General Careers with the Pharmaceutical Industry 149 13 The Role of the Pharmacist in Healthcare 151 David Jordan 14 Careers for Nurses with the Pharmaceutical Industry 163 Joyce E. Kenkre 15 The Toxicologist in Pharmaceutical Medicine 177 Geoffrey Diggle 16 A Career in Clinical Quality Assurance 187 Rita Hattemer-Apostel 17 A Career in Product Registration and Regulatory Affairs 203 Pat Turmer 18 Careers in Drug Safety and Pharmacovigilance 213 Peter Barnes 19 Careers in Medical Information 223 Janet Taylor 20 Medical Writing as a Career 235 Brenda M. Mullinger 21 Career Opportunities in Medicines Regulation—The Medical Assessor 247 Nigel Baber 22 Pharmaceutical Law—A Growing Legal Specialty 255 Ian Dodds-Smith CONTENTS vii 23 Industry Careers for Pharmacoeconomists 267 Nick Bosanquet 24 Consultant in Pharmaceutical Medicine 275 Brian Gennery V Career Progression 287 25 Landing that Job—Recruitment, CVs and Interviews 289 Sue Ransom 26 Career Development in Pharmaceuticals 303 Roger D. Stephens 27 Opportunities for Education and Training in the Pharmaceutical Industry 311 Peter D. Stonier and Gareth Hayes Useful Information 337 Index 341 List of Contributors Professor Nigel Baber Caroline Crockatt Medicines Control Agency Intercern Ltd Market Towers Linden House 1 Nine Elms Lane 5 High Street London SW8 5NQ Reigate UK Surrey RH2 9AE UK Dr Peter Barnes Aventis Pharma Pty Ltd 27 Sirius Road Lane Cove Dr Geoffrey Diggle NSW 2066 Formerly Department of Health Australia Skipton House 89 London Road Dr Jane Barrett London SE1 6LW The Barrett Consultancy UK 2 Falcon Way Wokingham Berkshire RG41 3HD Mr Ian Dodds-Smith UK Arnold & Porter Professor Nick Bosanquet Tower 42 Department of Bioengineering 25 Old Broad Street Imperial College London EC2N 1HQ Bagrit Centre UK Exhibition Road London SW7 2BX UK Dr David Ellis Roy Carlisle Euromedica plc PharmaSolutions Ltd 6a Enterprise House 10 Goddington Road Vision Park Bourne End Histon Buckinghamshire SL8 5TZ Cambridge CB4 9ZR UK UK CareerswiththePharmaceuticalIndustry,Secondedition.EditedbyP.D.Stonier. &2003JohnW|ley&SonsLtd x LISTOFCONTRIBUTORS Dr Felicity Gabbay Dr David Jordan 10 Park Lane Pharmaceutical Sciences Milford on Sea Quintiles (Europe) Ltd Hampshire Research Avenue South UK Heriot-Watt University Research Park Riccarton Dr Brian Gennery Edinburgh EH14 4AP Gennery Associates UK Pharmaceutical Consultancy 6 Qualitas Roman Hill Professor Joyce E. Kenkre Bracknell School of Care Sciences Berkshire RG12 7QG University of Glamorgan UK Research Unit Pontypridd CF37 1DL Professor Sir Charles F. George UK British Heart Foundation 14 Fitzhardinge Street London W1H 4DH Trevor Lewis UK Development Operations Pfizer Global Research & Development Rita Hattemer-Apostel Pfizer Ltd Verdandi AG Sandwich Wieslergasse 2 Kent CT13 9NJ 8049 Zurich UK Switzerland Gareth Hayes Brenda M. Mullinger nrg pathway Wordpower Projects PO Box 9 ‘Larches’ Appleby-in-Westmorland Shipbourne Cumbria CA16 6YF Kent TN11 9PL UK UK Christopher Hilton Development Operations Nicola Murgatroyd Pfizer Global Research & Phlexglobal Ltd Development Dairy House Pfizer Ltd Churchfield Road Sandwich Chalfont St Peter Kent CT13 9NJ Bucks SL9 9EW UK UK LISTOFCONTRIBUTORS xi Sue Ransom Janet Taylor AXESS Ltd Janet Taylor Consultancy Services Parkshot House 19 Nations Hill 5 Kew Road Kingsworthy Richmond Winchester Surrey TW9 2PR Hants SO23 7QY UK UK Professor Bert Spilker Dr Pat Turmer Bert Spilker & Associates, LLC 131 Charlton Road 8004 Overhill Road Kenton Bethesda, MD 20814-1145 London HA3 9HT USA UK Roger D. Stephens Ms Sheila Varley RSA Consulting Ltd Quintiles Ltd The Melon Ground Station House Hatfield Park Market Street Old Hatfield Bracknell Herts AL9 5NB Berkshire RG12 1HX UK UK Dr Peter D. Stonier Dr Roger Yates AXESS Ltd Astra Zeneca Ltd Parkshot House Mereside 5 Kew Road Alderley Park Richmond Macclesfield Surrey TW9 2PR Cheshire SK10 4TG UK UK Preface The ¢rsteditionof thisbookappeared in1994and hasbeen received favourably enoughsince towarrantasecondeditionsome nineyearslater.The originaltitle ‘Discovering New Medicines’appeared a little opaque for those seeking tolearn aboutcareersin medicinesresearch and development.So for this second edition theopportunityhasbeentakentosayitasitis:‘CareerswiththePharmaceutical Industry’.Thisre£ectscareersbothintheindustry,whichintheUKemployssome 60000people,andthosesupporting,servicingandregulating theindustryinits contribution to medicines research, representing up to 250000 people, in academia,healthcare,government,contractresearchandconsultancy. Asbefore,itisnotpossibletocoverallthevariantsofjobsandcareersthatexist inthiscomplexandevolvingindustry;notablyabsentisthemanufacturingsector, businessmanagementandadministration.However,itishopedthereareenough entry points thatare recognisable,so thatlight is thrown on the di¡erentcareer courses in pharmaceuticals, at the core of which are research and development, marketingandsales. Nine years is not long in the life-cycle of a pharmaceutical product, in that it takesonaverage12yearstodevelopanewmedicinefrompromisingnewmolecules discovered in thelaboratory,andthose thatwerein earlydevelopmentwhen this book¢rstappearedareonlynowbeingintroducedontothemarketforthebene¢t ofpatients.Theprinciplesofconsistentendeavourbyprofessionalsachievingincre- mentalprogress in knowledge and technical application in new products, which werelaidoutintheprefacetothe¢rstedition,arestillvalidtoday. Nevertheless,throughoutthe1990sand2000stherehavebeenmanychangesin theenvironmentofmedicinesresearch;changesinphilosophy,direction,organisa- tion, communication, ¢nancing and regulation. Much of this perhaps re£ects a natural competitive evolution of renewal and re-engineering, responding to the economic business cycle and to the relative merits and successes of individual products,aswellas to the potentialoffuture product pipelines.The mappingof the human genome, the growth of information technology through increased computing powerand communicationsviatheInternet,and the globalisation of medicinesR&Dtointernationalstandardsarejustsomeofthechangeswhichwill CareerswiththePharmaceuticalIndustry,Secondedition.EditedbyP.D.Stonier. &2003JohnW|ley&SonsLtd