SlideShare a Scribd company logo
1 of 9
CurriculumVitae – Nanna Keeling (MSc Dip MPharm)
Personal Details
Name: NannaKeeling
Address:Brannemysten1B,436 55, Hovas, Sweden
Mobile:+46 (0) 727370641
LinkedIn:http://se.linkedin.com/pub/nanna-keeling/1/917/746
Career summary
Overthe past 20 yearsI have beenworkinginvariousdisciplinesandtherapeuticareas of the
Pharmaceutical industry. The keyfeature of mycareerhas beenprojectmanagementof cross-
functional complexglobal clinical &drugdevelopment programs,ensuringtheirstrategicalignment
withcompany’score objectivesandtheirdeliverytotime,budgetandquality. Myexperience
stretchesfromdesign,set-upandleadingof earlyphase and largerglobal late phase clinical studies
to workingcloselywithFunctional Headsonimplementationof results. Ihave extensiveknowledge
of GCP/ICHguidelinesandFDA/EMEA regulationsandbeeninvolvedinregulatorysubmissions.
Leadershipof global &cross-functionalteamsandprojects,withreal passionfor myteamsand
customers hasbeenalwaysbeen keyfeature of mycareer.I alsohave experience fromworking
withexternal partnersandCROs,KOLs,andscientificAd-boardsandbeenresponsibleforbudget,
resources (incl.linemanagementof staff) andrisk andopportunitymanagementof multimillion
dollarprojects. Iam passionate abouthighqualityandethical deliveryof soundscientific/clinical
data to supportthe strategiesfordevelopinglifesavingdrugsandproducts.
Education & Qualifications
Master of Science inPharmacy, UppsalaUniversity,Sweden
Jan.1990 - June 1995
Postgraduate studies,Diplomain Pharmacy, UppsalaUniversity
Sept1995 - Aug.1996
EU-PharmacyPractice
Career Details
Pharmaceutical Advisorand Head of Pharmacy
May 2016- Ongoing
Lloyds Apotek
Vastra GotalandsRegion
Sweden
Global Clinical Lead
November2015 – April 2016
Thrombosis ResearchInstitute,London
Manresa Road, London SW3 6LR, UK
Key areasof responsibility:
Oversightandmanagementof the clinical operationsdepartmentatTRI London. Internationally
renownedforpioneering,multi-disciplinaryresearch,the ThrombosisResearchInstitute is
dedicatedtothe studyof thrombosisandrelateddisorders.The TRIisa charityand a purely
scientificresearchinstitute whichworksindependentlyasanacademicinstitution. The Institutes’
research programs aim to understandthe diseaseprocessanddevelopnovel andaffordable
therapiesinordertointervene topreventlongtermdisablementandearlydeath. Asglobal clinical
leadI workalongside the COOandmanage the Global & Regional ProjectManagers at the institute
and provide global strategicleadershipandoversightforthe on-goingandplannedclinical work.
For furtherinformationaboutthe currentandpastachievementsof the TRI,please goto www.TRI-
london.ac.uk
Freelance Medical Writer& Editor
January 2015 – November2015
FPEC UK,BN1 5BF, Brighton,UK
Keyareasof responsibility:
As a medical writerIcommunicate scientificresearchtoa professional orlayaudience,eitherfor
journals,promotionalbrochuresandwebsites.Myworkhas an elementof editingorbroader
communicationsresponsibilitiesinadditiontoresearchingandwriting. Thisrole isaproject
managementrole withinthe scientificpublicationsarena.
Global Medical Marketing& Evidence Director
March 2013 – October 2014
Mölnlycke HealthCare AB, Gothenburg,Sweden
Keyareasof responsibility;
● Headof Medical Marketing (Medical Affairs) &Evidence divisiongloballyforMölnlycke
HealthCare,includingline management of the staff (6directreports) andown budget
● Providingleadershiptothe managementteamforthe Medical MarketingInformation
supportfor all products& technologiesglobally
● Responsible forthe creationanddevelopmentof abrand new operatingmodel andrelated
processes (SOPs) forthe managementof scientificevidence atMolnlycke HealthCare
● Accountable forthe implementationof the new operatingmodel globally
● Responsible forsupportingstrategiesandtacticswhichdrive the developmentof evidence;
including,butnotlimitedtolaband benchtesting,animal studiesandclinical andfinancial
studiesinalignmentwithMölnlyckeHealthCare'sWoundCare Division’sbusinessneeds
● Directlyinvolvedinclinical studyprotocol development
● Monitor/collate performance indicatorsforthe Medical Marketing&Evidence Team
● Chairand headof the Clinical andEconomicEvidence Committee(CEEC)
● Coordinate anddirectworkloadforthe Medical Marketing& Evidence Team
● Accountable fortimely,accurate review andapproval of promotionalmaterialsin
accordance withthe relevantCodesof Practice bythe Medical Marketing & Evidence Team
● Accountable forthe developmentandmaintenanceof Medical Marketing andmedical
information’s SOPsandguidelines
● Provisionof scientificandtechnical supportandadvice toidentifyandsupportbusiness
developmentopportunities/productlaunchesandcontribute tothe developmentof
marketingcampaigns
● Representationof medical &scientificinformationinmultiplestrategicteamsand Core
TherapeuticTeams
● Responsible forkeepingup-to-datewithemergingtechnology/businessrequirementsand
the potential impactonthe business andreportingbacktothe board
● Responsible forteam’sactivitiestosupportmarketingandsalesactivities byproviding
scientific/medical information,enquiryhandling,clinical paperprovisionandtraining
● Responsible andaccountable forthe supportmarketingteamswithuptodate information
on products,disease areasandcompetitoractivity
● Representthe Medical Marketing&Evidence divisionbothinternallyandexternally
● Responsible forthe coordinationandprovisionof traininginthe fieldof medical &
scientificinformationandevidence management
SeniorManagementConsultant
October 2011 – Feb2013
Wenell MangamentAB,GothenburgSweden
Keyareasof responsibility;
 Providingmanagementconsultancytopharma/ biotech clientsonbehalf of the firm
 Reviewandassessmentof keystrategicprojectsonbehalf of the clientandidentifyareasof
riskand slippage (includingproposalsforimprovementandcontingencyplanning)and
generatingreportstothateffectforseniormanagementanddecisionmakingbodies
 Providinginput andadvice asa consultantintoprogramplanningeffortstogetherwiththe
supportingfunctions,client’sprojectmanagers andvendorstocreate operational plans
 Supportingandhelpdrive the coordinationof governance approvalsforthe keyproject
deliverables
Clinical InformationScience Director, Cardiovascular & Respiratory & InflammationTherapy Area
Aug 2008-Sept 2011
AstraZeneca R&D Molndal,Sweden
Keyareasof responsibility;
● SeniorR&D memberwithinthe ClinicalDevelopmentdivisionatAstraZeneca
● Core memberof the Clinical ProjectTeam,responsible forthe projectmanagementand
deliveryof the clinicalinformationscience componentsof one ormultipledrugproject
withinaspecificTherapeuticArea(TA)
● Leaderof a cross-functionalteamof multiple seniorleadersincl. biostatistics
(Global productStatistician),datamanagement(DataManagementProjectLeader),
Programming(Global ProgrammingLeader),medical authoring(Global Medical Writer),
scientificpublications(Global PublicationManager),clinical publication(GlobalClinical
PublicationLeader),regulatoryaffairs(RegulatoryAffairsManager),healtheconomics
(Global HEOR lead)
● Accountable fordeliveryof all clinical information components fromstarttofinishindrug
developmentprojects, includingprotocol development &signoff, the scientific
interpretation,reportingandpublishingof the data/informationforregulatorysubmissions
and scientificpublications
● Workingcross-functionallyandglobally withkeystakeholderssuchasRegulatoryAffairs,
Pharmacovigilance,Marketingandheadof TA to ensure projectswere continuouslyaligned
to core strategicobjectivesandsubmissionsandapproval deadlineswere kept
● Accountable forcommunicationof keystrategicmaterialtobothinternal seniorR&D
stakeholdersanddecisionmakers,suchasthe PortfolioReview Boardandexternallyat
scientificmeetings
● As the projectmanagerforInformationSciencesinthe TA;responsibleforestablishing,
communicatingandexecutingplansinordertoachieve projectgoals including
● Accountable forthe on-time,accurate andqualityassureddeliveryof all the clinical
componentsof ourassigneddrugprojects includingidentifyinganddrivingprojectand
resource prioritiesthatalignwiththe businessobjectives
Global ProjectManager, Symbicort® Global Product Team
May 2006-July 2008
AstraZeneca R&D Lund, Sweden
Keyareasof responsibility:
● SeniorR&D role withinthe DevelopmentProjectsorganisationwith cross-functional project
managementaccountability,reportingdirectlytothe VPGlobal ProductDirector(VPGPD).
● Memberof the Global ProductTeam(GPT)
● Responsible forthe coordinationof the GPT activities,suchasmeetings,minutesand
disseminationof actionsanddecisionstofunctional deliveryteams
● Responsible forprovidinglinemanagement teamwithinputincross-functional delivery
team’sperformance andactive memberof the appraisal team
● Responsible forprovidingsubjectmatterexpertinputand part of final draftapproval
processof clinical studyprotocols
● As GPMresponsibleforall PMactivitieswithinthe GPTincluding;
- Riskmanagementthroughproactivelyidentifyingpotentialissuesorobstaclesand
developingsolutionsorcontingencypwithappropriate follow upprocessestill
resolution
- Managementof projectstatusreportsboth forplannedorad-hocitems
- Responsible forensuringthe involvementof all appropriate regional teams,functions
and divisions(includingexternal partnersorservice providers) inrelevant
communications,decisionsandworkinggroups –statusupdateson a weeklybasisto
the GPT
- Responsible foridentifyinganddrivingprojectandresource prioritiesthatalignwith
the businessobjectives
- Responsible forgeneratingglobal communicationplansonbehalf of the GPTandthe
disseminationof the plantoregional,functional anddivisional teams(incl.external
partners) – Ensuringclearcommunicationandplanningacrossthe project(Symbicort)
● Involvedandcontributed toall decisionspertainingtothe successful developmentandLife
Cycle Managementactivitiesforthe productandthe leadershipof multiple DeliveryTeams
(DT) – I.e. US NDA Submissionof Symbicort,JapanRegulatorysubmissionTeam, EU& RoW
DT for the developmentof newstrategiesforfurthermarketaccess (incl the Rapihaler
Project)
Global Clinical Study Leader,Nexium® & Crestor®
Sept 2000-May 2006
AstraZeneca R&D Mölndal
Keyareasof responsibility;
● Global clinical programleadandresponsible projectmanagerforthe clinical operations
aspectsof the studies
● Accountable andresponsible forthe deliveryof clinical studiesfromearlytolate phase of
developmentandmultipletherapyareasaccordingtoGCP and internal companystandards
and SOPs
● Responsible andaccountable fordevelopingclinical studyprotocolsandfinal approval
● Projectmanagementof the operationalplansensuringstudy delivery totime,budgetand
quality
● Identifyingandmanagingriskswithinthe projectsandworkingcollaborativelytodeliver
solidsolutionsorcontingencyplans
● Responsible forcommunicationplansforthe project,globally
● Responsible forprojectplanninganddeliveryof monitorsmeetings,investigatormeetings,
endof studymeetings
● Representingthe clinical studyteamandprojectinternallyandexternallyona global scale
● Workingcross-functionallyandcross-regionallytoensure projecttimelinesanddeliverables
were kept
● Commissioningauditsof internal projectteamandinvestigatorssitesandworkingclosely
withthe internal QA teamto enable suchaudits,includingreportingbacktoHead of Clinical
TA
SeniorDrug/Device SafetyScientist,Diabetes& Neurology
March 1998 – Aug. 2000
Eli Lilly& CompanyErl WoodManor, Windlesham,SurreyGU20 6PH, UK
Keyareasof responsibility;
 Pharmacovigilancescientistresponsible foranalysingandreportingof safetyreports
 Responsible forprocessimprovementandSOPdevelopmentwithinthe PV-departmenton
a global scale
SeniorMedical Information Executive
Dec. 1996 – Feb.1998
Warner Lambert Parke Davis, Eastleigh,Hants, SO53 3ZQ, UK
Keyareasof responsibility;
● Medical Informationexecutive providingscientificandmedical supportfor all productsin
the UK.
● Deputyto the Headof Medical Informationdepartmentasrequired
● Monitoringandcollationof performance indicatorsforthe Medical InformationTeam –
auditthe Medical EnquiryDatabase and setstandardsas and whenrequired.
● Responsible forensuringthatmedical enquirieswere handledinaccordance withthe PIPA
guidelines
● Maintainand developMedical InformationITandlibraryresources
● Timely,accurate reviewandapproval of promotionalmaterialsinaccordance withthe
relevantCodesof Practice bythe Medical InformationTeam
● KeyContributortothe developmentandmaintenance of Medical InformationBOPsand
guidelines
● Part of team which operatedandprovidedsupportforthe 24 hour medical on-call service
● Preparingstandardletters,productsummaries/reviews,formularypacks.
● Responsible forthe supporttomarketingandsalesactivitiesbyprovidingscientific/medical
information,enquiryhandling,clinical paperprovisionandtraining
● Supportmarketingteamswithupto date informationonproducts,disease areasand
competitoractivity
● Responsible forproductinformationtraining
Scientific Publications
Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, PreiksaitisH, Keeling N,
Nauclér E, Eklund S, Juergens H. A randomized comparativestudy of esomeprazole 40 mg versus
pantoprazole40 mg for healingerosiveoesophagitis:the EXPO study. Alimentary Pharmacology &
Therapeutics 2005;21(6):739-46
Bayerdörffer E, Sipponen P, Bigard M, Weiss W,Mearin F, Rodrigo L, Dominguez Muñoz J, GrundlingH,
Nauclér E, Svedberg L, Keeling N, Eklund S. Esomeprazole 20 mg continuous versus on demand treatment of
patients with endoscopy-negative reflux disease(ENRD). Gut 2004;53(Suppl VI):A106, Abs MON-G-168
Bayerdörffer E, Sipponen P, Nauclér E, Svedberg LE, KeelingN, Eklund S. Esomeprazole 20 mg on-demand
compared to long-term therapy in patients with non-erosive esophageal reflux disease(NERD). Zeitschriftfür
Gastroenterologie 2004;42(8):Abs P055.
Labenz J, KeelingN, Eklund S, Nauclér E. A comparison of esomeprazole 40 mg once-daily and pantoprazole
40 mg once-daily for the healingof erosiveesophagitis. Can J
Gastroenterol 2004;vol 18 Suppl A: abstract147
Labenz J, KeelingN, Eklund S, Nauclér E. Treatment of erosivereflux esophagitis with esomeprazole and
pantoprazole: results froma randomized, double-blind multicenter study (EXPO). Zeitschriftfür
Gastroenterologie 2004;42(8):Abs V007
Labenz J, KeelingN, Eklund S. A comparison of esomeprazole 40 mg once-daily and pantoprazole40 mg once-
daily for the healingof reflux oesophagitis.Gut 2003; 52
(Suppl VI) A241
Labenz J, Naucler E, Keeling N, Eklund S. Esomeprazole 40 mg heals significantly more Helicobacter pylori -
negative erosiveesophagitis patients than pantoprazole40 mg. Gastroenterology 2004;126(4 Suppl 2):A-338,
Abs M1458.
Schmidt S, Keeling N, Eklund S, Naucler E, Labenz J. A comparison of esomeprazole 40 mg once-daily and
pantoprazole40 mg once-daily for the healingof erosiveesophagitis. SAMJ South African Medical Journal
2004;94(8):688.
Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, Juergens H, Preiksaitis H,
Keeling N, Nauclér E, Adler J, Eklund S. Esomeprazole 20 mg versus pantoprazole20 mg for maintenance
therapy of healed erosiveesophagitis:results fromthe EXPO study. in press 2005 Alimentary Pharmacology
and Therapeutics
Membershipof Professional Bodies
Memberof: The Royal Pharmaceutical Societyof GreatBritain,andmemberof AIOPI&Institute of
Clinical Research.The SwedishPharmaceutical Associationandthe SwedishPharmacistAssociation,
Registered&licensedpharmacistwiththe SwedishNational Boardof Health.
References
Provided upon request.
Interests andHobbies
I love spendingqualitytime withmyfamily.Iamalsoa fitness&travel enthusiast.
List of Clinical Study Work – 2000 - 2011
Role on Study (e.g.
CRA, CPM etc.)
Indication Phase No. of
patients
No. of
sites
Countries involved Services involved
(e.g. full service or
just clinical)
Stages of study involved (e.g. set u
etc.)
Clinical Study/
programme Leader
Erosive
oesophagiti
s
IV 3000 <250 Australia, Brazil,
Argentina,
Poland, Slovakia,
Romania, Hungary, UK,
Germany, Russia,
Bulgaria, Switzerland,
Sweden,
Denmark, Greece, France,
Spain, Canada
R&D funded trial, as
study / program lead
all services
were managed
All stages from start (CSP w
Clinical Study/
programme Leader
endoscopy-
negative
reflux
disease
(ENRD)
IIIb 450 56 Germany, Poland, UK,
Switzerland, Denmark,
Hungary
R&D funded trial, as
study / programme
lead all services
were managed
All stages from start (CSP w
Clinical Study/
programme Leader
endoscopy-
negative
reflux
disease
(ENRD)
IIIa 250 30 Germany, Poland,
Switzerland, Denmark,
Hungary
R&D funded trial, as
study / programme
lead all services
were managed
All stages from start (CSP w
Clinical Study/
programme Leader
Heart
failure
IIIb/IV 5011 371 19 European countries,
Russia, and South Africa
R&D funded trial, as
study / programme
lead all services
were managed
All stages from start (CSP w
Clinical Information
Science Director
member of the
Clinical project Team
COPD (S&T) IIa 87 10 Bulgaria, Germany,
Hungary,
Ukraine
R&D funded,
outsourced to CRO
for conduct.
Involved in study design concept, d
handover to CRO, collaboration wi
progression and taking over from i
Clinical Information
Science Director
member of the
Clinical project Team
COPD
(Bronchiect
asis)
IIb 52 8 UK, Czech Republic,
Poland.
R&D funded,
outsourced to CRO
for conduct.
Involved in study design concept, d
handover to CRO, collaboration wi
progression and taking over from i
Clinical Information
Science Director
member of the
Clinical project Team
COPD I
(JS
AD/
JMAD
)
63 1 UK
(Japanese subjects
recruited in UK)
R&D funded,
outsourced
to CRO for
conduct
Involved in study design concept, drawing up agre
and handover to CRO, collaboration with CRO thro
study progression and taking over from interpreta
stage
Clinical Information
Science Director
member of the
Clinical project Team
COPD I
(ADM
E)
6 1 UK R&D funded,
in-house
study
Overseeing all aspects from start to finish – from
CSP to CSR & Publication
Clinical Information
Science Director
member of the
Clinical project Team
COPD
(S&T)
IIa 63 4 Bulgaria, Slovakia. R&D funded,
outsourced
to CRO for
conduct
Involved in study design concept, drawing up agre
CRO, collaboration with CRO throughout study pro
from interpretation stage
Clinical Information
Science Director
member of the
Clinical project Team
COPD IIb 43 3 Germany R&D funded,
outsourced
to CRO for
conduct
Involved in study design concept, drawing up agre
CRO, collaboration with CRO throughout study pro
from interpretation stage
Clinical Information
Science Director
member of the
Clinical project Team
Oral Anti-
Arrhythmia
IIa 125 12 CEE, Germany, UK R&D funded
trial, In-
house study
management
Involved in all aspects from start to finish, CSP to
CSR & Publication
Clinical Information
Science Director
member of the
Clinical project Team
Oral Anti-
Arrhythmia
I 75 1 Japan R&D funded
trial, In-
house study
management
Involved in all aspects from start to finish, , CSP to
CSR & Publication
Clinical Information
Science Director
member of the
Clinical project Team
Oral Anti-
Arrhythmia
IIb 112 7 CEE, Germany, UK,
Switzerland
R&D funded
trial, In-
house study
management
Involved all aspects from start to finish, , CSP to CS
& Publication

More Related Content

What's hot

HA TRUONG- RESUME+CERTIFICATES 2016-
HA TRUONG- RESUME+CERTIFICATES 2016-HA TRUONG- RESUME+CERTIFICATES 2016-
HA TRUONG- RESUME+CERTIFICATES 2016-THI HONG HA TRUONG
 
Research support including planning and excution of clinical trails
Research support including planning and excution of clinical trailsResearch support including planning and excution of clinical trails
Research support including planning and excution of clinical trailsPooja Anothra
 
Outsourcing Paediatric Investigation Plans
Outsourcing Paediatric Investigation PlansOutsourcing Paediatric Investigation Plans
Outsourcing Paediatric Investigation Plansjbarag
 
Planning your Paediatric Investigation Plan (PIP) Submission in Europe
Planning your Paediatric Investigation Plan (PIP) Submission in EuropePlanning your Paediatric Investigation Plan (PIP) Submission in Europe
Planning your Paediatric Investigation Plan (PIP) Submission in Europejbarag
 

What's hot (7)

HA TRUONG- RESUME+CERTIFICATES 2016-
HA TRUONG- RESUME+CERTIFICATES 2016-HA TRUONG- RESUME+CERTIFICATES 2016-
HA TRUONG- RESUME+CERTIFICATES 2016-
 
Meditep. Corporate Dossier
Meditep. Corporate DossierMeditep. Corporate Dossier
Meditep. Corporate Dossier
 
Research support including planning and excution of clinical trails
Research support including planning and excution of clinical trailsResearch support including planning and excution of clinical trails
Research support including planning and excution of clinical trails
 
CPG ADAPTATION METHODOLOGY
CPG ADAPTATION METHODOLOGYCPG ADAPTATION METHODOLOGY
CPG ADAPTATION METHODOLOGY
 
ClinActis FSP Model
ClinActis FSP ModelClinActis FSP Model
ClinActis FSP Model
 
Outsourcing Paediatric Investigation Plans
Outsourcing Paediatric Investigation PlansOutsourcing Paediatric Investigation Plans
Outsourcing Paediatric Investigation Plans
 
Planning your Paediatric Investigation Plan (PIP) Submission in Europe
Planning your Paediatric Investigation Plan (PIP) Submission in EuropePlanning your Paediatric Investigation Plan (PIP) Submission in Europe
Planning your Paediatric Investigation Plan (PIP) Submission in Europe
 

Viewers also liked (14)

Keith kelley Airframe and powerplant resume
Keith kelley Airframe and powerplant resumeKeith kelley Airframe and powerplant resume
Keith kelley Airframe and powerplant resume
 
Resume1HH^JDaniel Arnold
Resume1HH^JDaniel ArnoldResume1HH^JDaniel Arnold
Resume1HH^JDaniel Arnold
 
cv-onks 2
cv-onks 2cv-onks 2
cv-onks 2
 
Jaga CV
Jaga CVJaga CV
Jaga CV
 
CV-Zaykova
CV-ZaykovaCV-Zaykova
CV-Zaykova
 
Tshomarelo Abueng CV
Tshomarelo Abueng CVTshomarelo Abueng CV
Tshomarelo Abueng CV
 
SEGADIMO CV
SEGADIMO  CV SEGADIMO  CV
SEGADIMO CV
 
091114 Cv Stephane Jeannet
091114 Cv Stephane Jeannet091114 Cv Stephane Jeannet
091114 Cv Stephane Jeannet
 
CV EUROPASS NIKOLAOS KOLETSIS
CV EUROPASS NIKOLAOS KOLETSISCV EUROPASS NIKOLAOS KOLETSIS
CV EUROPASS NIKOLAOS KOLETSIS
 
Nenguba CV
Nenguba CVNenguba CV
Nenguba CV
 
CURRICULLUM VITAE
CURRICULLUM VITAECURRICULLUM VITAE
CURRICULLUM VITAE
 
original cv
original cvoriginal cv
original cv
 
Human security in 2016 Botswana
Human security in 2016 BotswanaHuman security in 2016 Botswana
Human security in 2016 Botswana
 
JACK CV updated
JACK CV updatedJACK CV updated
JACK CV updated
 

Similar to Nanna Keeling CV 2016

Similar to Nanna Keeling CV 2016 (20)

Senior Fellow
Senior FellowSenior Fellow
Senior Fellow
 
Murray CV 2016
Murray CV 2016Murray CV 2016
Murray CV 2016
 
linkedin summary
linkedin summarylinkedin summary
linkedin summary
 
Resume Stephen Jones. 2015
Resume Stephen Jones. 2015Resume Stephen Jones. 2015
Resume Stephen Jones. 2015
 
Program Operation Manager - Basel, Switzerland
Program Operation Manager - Basel, SwitzerlandProgram Operation Manager - Basel, Switzerland
Program Operation Manager - Basel, Switzerland
 
helen_harger_cv
helen_harger_cvhelen_harger_cv
helen_harger_cv
 
Holly Whitten Scott - g resume May 2016
Holly Whitten Scott - g resume May 2016Holly Whitten Scott - g resume May 2016
Holly Whitten Scott - g resume May 2016
 
Walter King Resume 2015
Walter King Resume 2015Walter King Resume 2015
Walter King Resume 2015
 
Davidtwersky 2-2016-2
Davidtwersky 2-2016-2Davidtwersky 2-2016-2
Davidtwersky 2-2016-2
 
gkaur_Resume_CMA
gkaur_Resume_CMAgkaur_Resume_CMA
gkaur_Resume_CMA
 
Clinical Pharmacology Expert
Clinical Pharmacology ExpertClinical Pharmacology Expert
Clinical Pharmacology Expert
 
BOB WICK Resume November 2015
BOB WICK Resume November 2015BOB WICK Resume November 2015
BOB WICK Resume November 2015
 
Bob wick resume november 2015
Bob wick resume november 2015Bob wick resume november 2015
Bob wick resume november 2015
 
Nicole Mutschler 2015 Revised
Nicole Mutschler 2015 RevisedNicole Mutschler 2015 Revised
Nicole Mutschler 2015 Revised
 
William HatfieldResume052015Current
William HatfieldResume052015CurrentWilliam HatfieldResume052015Current
William HatfieldResume052015Current
 
Howard Eney Resume FINAL
Howard Eney Resume FINALHoward Eney Resume FINAL
Howard Eney Resume FINAL
 
Finnj7
Finnj7Finnj7
Finnj7
 
MJ2014Resume
MJ2014ResumeMJ2014Resume
MJ2014Resume
 
JOB DESCRIPTION Dir Med Prod
JOB DESCRIPTION Dir Med ProdJOB DESCRIPTION Dir Med Prod
JOB DESCRIPTION Dir Med Prod
 
Cv edgard english_2014
Cv edgard english_2014Cv edgard english_2014
Cv edgard english_2014
 

Nanna Keeling CV 2016

  • 1. CurriculumVitae – Nanna Keeling (MSc Dip MPharm) Personal Details Name: NannaKeeling Address:Brannemysten1B,436 55, Hovas, Sweden Mobile:+46 (0) 727370641 LinkedIn:http://se.linkedin.com/pub/nanna-keeling/1/917/746 Career summary Overthe past 20 yearsI have beenworkinginvariousdisciplinesandtherapeuticareas of the Pharmaceutical industry. The keyfeature of mycareerhas beenprojectmanagementof cross- functional complexglobal clinical &drugdevelopment programs,ensuringtheirstrategicalignment withcompany’score objectivesandtheirdeliverytotime,budgetandquality. Myexperience stretchesfromdesign,set-upandleadingof earlyphase and largerglobal late phase clinical studies to workingcloselywithFunctional Headsonimplementationof results. Ihave extensiveknowledge of GCP/ICHguidelinesandFDA/EMEA regulationsandbeeninvolvedinregulatorysubmissions. Leadershipof global &cross-functionalteamsandprojects,withreal passionfor myteamsand customers hasbeenalwaysbeen keyfeature of mycareer.I alsohave experience fromworking withexternal partnersandCROs,KOLs,andscientificAd-boardsandbeenresponsibleforbudget, resources (incl.linemanagementof staff) andrisk andopportunitymanagementof multimillion dollarprojects. Iam passionate abouthighqualityandethical deliveryof soundscientific/clinical data to supportthe strategiesfordevelopinglifesavingdrugsandproducts. Education & Qualifications Master of Science inPharmacy, UppsalaUniversity,Sweden Jan.1990 - June 1995 Postgraduate studies,Diplomain Pharmacy, UppsalaUniversity Sept1995 - Aug.1996 EU-PharmacyPractice Career Details Pharmaceutical Advisorand Head of Pharmacy May 2016- Ongoing Lloyds Apotek Vastra GotalandsRegion Sweden
  • 2. Global Clinical Lead November2015 – April 2016 Thrombosis ResearchInstitute,London Manresa Road, London SW3 6LR, UK Key areasof responsibility: Oversightandmanagementof the clinical operationsdepartmentatTRI London. Internationally renownedforpioneering,multi-disciplinaryresearch,the ThrombosisResearchInstitute is dedicatedtothe studyof thrombosisandrelateddisorders.The TRIisa charityand a purely scientificresearchinstitute whichworksindependentlyasanacademicinstitution. The Institutes’ research programs aim to understandthe diseaseprocessanddevelopnovel andaffordable therapiesinordertointervene topreventlongtermdisablementandearlydeath. Asglobal clinical leadI workalongside the COOandmanage the Global & Regional ProjectManagers at the institute and provide global strategicleadershipandoversightforthe on-goingandplannedclinical work. For furtherinformationaboutthe currentandpastachievementsof the TRI,please goto www.TRI- london.ac.uk Freelance Medical Writer& Editor January 2015 – November2015 FPEC UK,BN1 5BF, Brighton,UK Keyareasof responsibility: As a medical writerIcommunicate scientificresearchtoa professional orlayaudience,eitherfor journals,promotionalbrochuresandwebsites.Myworkhas an elementof editingorbroader communicationsresponsibilitiesinadditiontoresearchingandwriting. Thisrole isaproject managementrole withinthe scientificpublicationsarena. Global Medical Marketing& Evidence Director March 2013 – October 2014 Mölnlycke HealthCare AB, Gothenburg,Sweden Keyareasof responsibility; ● Headof Medical Marketing (Medical Affairs) &Evidence divisiongloballyforMölnlycke HealthCare,includingline management of the staff (6directreports) andown budget ● Providingleadershiptothe managementteamforthe Medical MarketingInformation supportfor all products& technologiesglobally ● Responsible forthe creationanddevelopmentof abrand new operatingmodel andrelated processes (SOPs) forthe managementof scientificevidence atMolnlycke HealthCare ● Accountable forthe implementationof the new operatingmodel globally ● Responsible forsupportingstrategiesandtacticswhichdrive the developmentof evidence; including,butnotlimitedtolaband benchtesting,animal studiesandclinical andfinancial studiesinalignmentwithMölnlyckeHealthCare'sWoundCare Division’sbusinessneeds ● Directlyinvolvedinclinical studyprotocol development ● Monitor/collate performance indicatorsforthe Medical Marketing&Evidence Team ● Chairand headof the Clinical andEconomicEvidence Committee(CEEC) ● Coordinate anddirectworkloadforthe Medical Marketing& Evidence Team ● Accountable fortimely,accurate review andapproval of promotionalmaterialsin accordance withthe relevantCodesof Practice bythe Medical Marketing & Evidence Team
  • 3. ● Accountable forthe developmentandmaintenanceof Medical Marketing andmedical information’s SOPsandguidelines ● Provisionof scientificandtechnical supportandadvice toidentifyandsupportbusiness developmentopportunities/productlaunchesandcontribute tothe developmentof marketingcampaigns ● Representationof medical &scientificinformationinmultiplestrategicteamsand Core TherapeuticTeams ● Responsible forkeepingup-to-datewithemergingtechnology/businessrequirementsand the potential impactonthe business andreportingbacktothe board ● Responsible forteam’sactivitiestosupportmarketingandsalesactivities byproviding scientific/medical information,enquiryhandling,clinical paperprovisionandtraining ● Responsible andaccountable forthe supportmarketingteamswithuptodate information on products,disease areasandcompetitoractivity ● Representthe Medical Marketing&Evidence divisionbothinternallyandexternally ● Responsible forthe coordinationandprovisionof traininginthe fieldof medical & scientificinformationandevidence management SeniorManagementConsultant October 2011 – Feb2013 Wenell MangamentAB,GothenburgSweden Keyareasof responsibility;  Providingmanagementconsultancytopharma/ biotech clientsonbehalf of the firm  Reviewandassessmentof keystrategicprojectsonbehalf of the clientandidentifyareasof riskand slippage (includingproposalsforimprovementandcontingencyplanning)and generatingreportstothateffectforseniormanagementanddecisionmakingbodies  Providinginput andadvice asa consultantintoprogramplanningeffortstogetherwiththe supportingfunctions,client’sprojectmanagers andvendorstocreate operational plans  Supportingandhelpdrive the coordinationof governance approvalsforthe keyproject deliverables Clinical InformationScience Director, Cardiovascular & Respiratory & InflammationTherapy Area Aug 2008-Sept 2011 AstraZeneca R&D Molndal,Sweden Keyareasof responsibility; ● SeniorR&D memberwithinthe ClinicalDevelopmentdivisionatAstraZeneca ● Core memberof the Clinical ProjectTeam,responsible forthe projectmanagementand deliveryof the clinicalinformationscience componentsof one ormultipledrugproject withinaspecificTherapeuticArea(TA) ● Leaderof a cross-functionalteamof multiple seniorleadersincl. biostatistics (Global productStatistician),datamanagement(DataManagementProjectLeader), Programming(Global ProgrammingLeader),medical authoring(Global Medical Writer), scientificpublications(Global PublicationManager),clinical publication(GlobalClinical
  • 4. PublicationLeader),regulatoryaffairs(RegulatoryAffairsManager),healtheconomics (Global HEOR lead) ● Accountable fordeliveryof all clinical information components fromstarttofinishindrug developmentprojects, includingprotocol development &signoff, the scientific interpretation,reportingandpublishingof the data/informationforregulatorysubmissions and scientificpublications ● Workingcross-functionallyandglobally withkeystakeholderssuchasRegulatoryAffairs, Pharmacovigilance,Marketingandheadof TA to ensure projectswere continuouslyaligned to core strategicobjectivesandsubmissionsandapproval deadlineswere kept ● Accountable forcommunicationof keystrategicmaterialtobothinternal seniorR&D stakeholdersanddecisionmakers,suchasthe PortfolioReview Boardandexternallyat scientificmeetings ● As the projectmanagerforInformationSciencesinthe TA;responsibleforestablishing, communicatingandexecutingplansinordertoachieve projectgoals including ● Accountable forthe on-time,accurate andqualityassureddeliveryof all the clinical componentsof ourassigneddrugprojects includingidentifyinganddrivingprojectand resource prioritiesthatalignwiththe businessobjectives Global ProjectManager, Symbicort® Global Product Team May 2006-July 2008 AstraZeneca R&D Lund, Sweden Keyareasof responsibility: ● SeniorR&D role withinthe DevelopmentProjectsorganisationwith cross-functional project managementaccountability,reportingdirectlytothe VPGlobal ProductDirector(VPGPD). ● Memberof the Global ProductTeam(GPT) ● Responsible forthe coordinationof the GPT activities,suchasmeetings,minutesand disseminationof actionsanddecisionstofunctional deliveryteams ● Responsible forprovidinglinemanagement teamwithinputincross-functional delivery team’sperformance andactive memberof the appraisal team ● Responsible forprovidingsubjectmatterexpertinputand part of final draftapproval processof clinical studyprotocols ● As GPMresponsibleforall PMactivitieswithinthe GPTincluding; - Riskmanagementthroughproactivelyidentifyingpotentialissuesorobstaclesand developingsolutionsorcontingencypwithappropriate follow upprocessestill resolution - Managementof projectstatusreportsboth forplannedorad-hocitems - Responsible forensuringthe involvementof all appropriate regional teams,functions and divisions(includingexternal partnersorservice providers) inrelevant communications,decisionsandworkinggroups –statusupdateson a weeklybasisto the GPT - Responsible foridentifyinganddrivingprojectandresource prioritiesthatalignwith the businessobjectives
  • 5. - Responsible forgeneratingglobal communicationplansonbehalf of the GPTandthe disseminationof the plantoregional,functional anddivisional teams(incl.external partners) – Ensuringclearcommunicationandplanningacrossthe project(Symbicort) ● Involvedandcontributed toall decisionspertainingtothe successful developmentandLife Cycle Managementactivitiesforthe productandthe leadershipof multiple DeliveryTeams (DT) – I.e. US NDA Submissionof Symbicort,JapanRegulatorysubmissionTeam, EU& RoW DT for the developmentof newstrategiesforfurthermarketaccess (incl the Rapihaler Project) Global Clinical Study Leader,Nexium® & Crestor® Sept 2000-May 2006 AstraZeneca R&D Mölndal Keyareasof responsibility; ● Global clinical programleadandresponsible projectmanagerforthe clinical operations aspectsof the studies ● Accountable andresponsible forthe deliveryof clinical studiesfromearlytolate phase of developmentandmultipletherapyareasaccordingtoGCP and internal companystandards and SOPs ● Responsible andaccountable fordevelopingclinical studyprotocolsandfinal approval ● Projectmanagementof the operationalplansensuringstudy delivery totime,budgetand quality ● Identifyingandmanagingriskswithinthe projectsandworkingcollaborativelytodeliver solidsolutionsorcontingencyplans ● Responsible forcommunicationplansforthe project,globally ● Responsible forprojectplanninganddeliveryof monitorsmeetings,investigatormeetings, endof studymeetings ● Representingthe clinical studyteamandprojectinternallyandexternallyona global scale ● Workingcross-functionallyandcross-regionallytoensure projecttimelinesanddeliverables were kept ● Commissioningauditsof internal projectteamandinvestigatorssitesandworkingclosely withthe internal QA teamto enable suchaudits,includingreportingbacktoHead of Clinical TA SeniorDrug/Device SafetyScientist,Diabetes& Neurology March 1998 – Aug. 2000 Eli Lilly& CompanyErl WoodManor, Windlesham,SurreyGU20 6PH, UK Keyareasof responsibility;  Pharmacovigilancescientistresponsible foranalysingandreportingof safetyreports  Responsible forprocessimprovementandSOPdevelopmentwithinthe PV-departmenton a global scale
  • 6. SeniorMedical Information Executive Dec. 1996 – Feb.1998 Warner Lambert Parke Davis, Eastleigh,Hants, SO53 3ZQ, UK Keyareasof responsibility; ● Medical Informationexecutive providingscientificandmedical supportfor all productsin the UK. ● Deputyto the Headof Medical Informationdepartmentasrequired ● Monitoringandcollationof performance indicatorsforthe Medical InformationTeam – auditthe Medical EnquiryDatabase and setstandardsas and whenrequired. ● Responsible forensuringthatmedical enquirieswere handledinaccordance withthe PIPA guidelines ● Maintainand developMedical InformationITandlibraryresources ● Timely,accurate reviewandapproval of promotionalmaterialsinaccordance withthe relevantCodesof Practice bythe Medical InformationTeam ● KeyContributortothe developmentandmaintenance of Medical InformationBOPsand guidelines ● Part of team which operatedandprovidedsupportforthe 24 hour medical on-call service ● Preparingstandardletters,productsummaries/reviews,formularypacks. ● Responsible forthe supporttomarketingandsalesactivitiesbyprovidingscientific/medical information,enquiryhandling,clinical paperprovisionandtraining ● Supportmarketingteamswithupto date informationonproducts,disease areasand competitoractivity ● Responsible forproductinformationtraining Scientific Publications Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, PreiksaitisH, Keeling N, Nauclér E, Eklund S, Juergens H. A randomized comparativestudy of esomeprazole 40 mg versus pantoprazole40 mg for healingerosiveoesophagitis:the EXPO study. Alimentary Pharmacology & Therapeutics 2005;21(6):739-46 Bayerdörffer E, Sipponen P, Bigard M, Weiss W,Mearin F, Rodrigo L, Dominguez Muñoz J, GrundlingH, Nauclér E, Svedberg L, Keeling N, Eklund S. Esomeprazole 20 mg continuous versus on demand treatment of patients with endoscopy-negative reflux disease(ENRD). Gut 2004;53(Suppl VI):A106, Abs MON-G-168 Bayerdörffer E, Sipponen P, Nauclér E, Svedberg LE, KeelingN, Eklund S. Esomeprazole 20 mg on-demand compared to long-term therapy in patients with non-erosive esophageal reflux disease(NERD). Zeitschriftfür Gastroenterologie 2004;42(8):Abs P055. Labenz J, KeelingN, Eklund S, Nauclér E. A comparison of esomeprazole 40 mg once-daily and pantoprazole 40 mg once-daily for the healingof erosiveesophagitis. Can J Gastroenterol 2004;vol 18 Suppl A: abstract147
  • 7. Labenz J, KeelingN, Eklund S, Nauclér E. Treatment of erosivereflux esophagitis with esomeprazole and pantoprazole: results froma randomized, double-blind multicenter study (EXPO). Zeitschriftfür Gastroenterologie 2004;42(8):Abs V007 Labenz J, KeelingN, Eklund S. A comparison of esomeprazole 40 mg once-daily and pantoprazole40 mg once- daily for the healingof reflux oesophagitis.Gut 2003; 52 (Suppl VI) A241 Labenz J, Naucler E, Keeling N, Eklund S. Esomeprazole 40 mg heals significantly more Helicobacter pylori - negative erosiveesophagitis patients than pantoprazole40 mg. Gastroenterology 2004;126(4 Suppl 2):A-338, Abs M1458. Schmidt S, Keeling N, Eklund S, Naucler E, Labenz J. A comparison of esomeprazole 40 mg once-daily and pantoprazole40 mg once-daily for the healingof erosiveesophagitis. SAMJ South African Medical Journal 2004;94(8):688. Labenz J, Armstrong D, Lauritsen K, Katelaris P,SchmidtS, Schütze K, Wallner G, Juergens H, Preiksaitis H, Keeling N, Nauclér E, Adler J, Eklund S. Esomeprazole 20 mg versus pantoprazole20 mg for maintenance therapy of healed erosiveesophagitis:results fromthe EXPO study. in press 2005 Alimentary Pharmacology and Therapeutics Membershipof Professional Bodies Memberof: The Royal Pharmaceutical Societyof GreatBritain,andmemberof AIOPI&Institute of Clinical Research.The SwedishPharmaceutical Associationandthe SwedishPharmacistAssociation, Registered&licensedpharmacistwiththe SwedishNational Boardof Health. References Provided upon request. Interests andHobbies I love spendingqualitytime withmyfamily.Iamalsoa fitness&travel enthusiast. List of Clinical Study Work – 2000 - 2011 Role on Study (e.g. CRA, CPM etc.) Indication Phase No. of patients No. of sites Countries involved Services involved (e.g. full service or just clinical) Stages of study involved (e.g. set u etc.) Clinical Study/ programme Leader Erosive oesophagiti s IV 3000 <250 Australia, Brazil, Argentina, Poland, Slovakia, Romania, Hungary, UK, Germany, Russia, Bulgaria, Switzerland, Sweden, Denmark, Greece, France, Spain, Canada R&D funded trial, as study / program lead all services were managed All stages from start (CSP w
  • 8. Clinical Study/ programme Leader endoscopy- negative reflux disease (ENRD) IIIb 450 56 Germany, Poland, UK, Switzerland, Denmark, Hungary R&D funded trial, as study / programme lead all services were managed All stages from start (CSP w Clinical Study/ programme Leader endoscopy- negative reflux disease (ENRD) IIIa 250 30 Germany, Poland, Switzerland, Denmark, Hungary R&D funded trial, as study / programme lead all services were managed All stages from start (CSP w Clinical Study/ programme Leader Heart failure IIIb/IV 5011 371 19 European countries, Russia, and South Africa R&D funded trial, as study / programme lead all services were managed All stages from start (CSP w Clinical Information Science Director member of the Clinical project Team COPD (S&T) IIa 87 10 Bulgaria, Germany, Hungary, Ukraine R&D funded, outsourced to CRO for conduct. Involved in study design concept, d handover to CRO, collaboration wi progression and taking over from i Clinical Information Science Director member of the Clinical project Team COPD (Bronchiect asis) IIb 52 8 UK, Czech Republic, Poland. R&D funded, outsourced to CRO for conduct. Involved in study design concept, d handover to CRO, collaboration wi progression and taking over from i Clinical Information Science Director member of the Clinical project Team COPD I (JS AD/ JMAD ) 63 1 UK (Japanese subjects recruited in UK) R&D funded, outsourced to CRO for conduct Involved in study design concept, drawing up agre and handover to CRO, collaboration with CRO thro study progression and taking over from interpreta stage Clinical Information Science Director member of the Clinical project Team COPD I (ADM E) 6 1 UK R&D funded, in-house study Overseeing all aspects from start to finish – from CSP to CSR & Publication Clinical Information Science Director member of the Clinical project Team COPD (S&T) IIa 63 4 Bulgaria, Slovakia. R&D funded, outsourced to CRO for conduct Involved in study design concept, drawing up agre CRO, collaboration with CRO throughout study pro from interpretation stage Clinical Information Science Director member of the Clinical project Team COPD IIb 43 3 Germany R&D funded, outsourced to CRO for conduct Involved in study design concept, drawing up agre CRO, collaboration with CRO throughout study pro from interpretation stage Clinical Information Science Director member of the Clinical project Team Oral Anti- Arrhythmia IIa 125 12 CEE, Germany, UK R&D funded trial, In- house study management Involved in all aspects from start to finish, CSP to CSR & Publication Clinical Information Science Director member of the Clinical project Team Oral Anti- Arrhythmia I 75 1 Japan R&D funded trial, In- house study management Involved in all aspects from start to finish, , CSP to CSR & Publication
  • 9. Clinical Information Science Director member of the Clinical project Team Oral Anti- Arrhythmia IIb 112 7 CEE, Germany, UK, Switzerland R&D funded trial, In- house study management Involved all aspects from start to finish, , CSP to CS & Publication