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Senior Medical Writer (Søborg, Denmark)

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Senior Medical Writer

- Research & Development
- Denmark - Søborg

Clinical Reporting is looking for a senior medical writer. You will be offered a challenging job with a significant amount of individual responsibility, and good personal development opportunities in an international and dynamic atmosphere.

About the Department
Clinical Reporting is the medical writing function at Novo Nordisk and is part of Global Development. We are currently 60+ employees, primarily medical writers and clinical publishers. We are a diverse group with different nationalities and professional backgrounds working together in a pleasant and informal atmosphere. We are responsible for preparing clinical documents for submission to regulatory authorities worldwide as well as abstracts and posters for scientific conferences and manuscripts to scientific journals.

The job
As a medical writer, your main tasks involve preparation of complex clinical documents within Novo Nordisk’s different therapy areas. Planning and coordination of activities in a cross-disciplinary setting is a central part of the job. Your main collaboration partners include clinicians, statisticians, regulatory affairs professionals, trial managers and data managers from Novo Nordisk headquarters and international affiliates. All documents are written in English and must comply with internal Novo Nordisk standard operating procedures as well as external guidelines.

Qualifications
You have a university degree within natural sciences (MD, M.Sc., M.Sc.Pharm. or equivalent) including skills within statistics and scientific research methods, and you have experience with medical writing. You master written and spoken English at a professional level, and you have a flair for, and a genuine interest in scientific communication. You are a strong team player who adapts easily to a changing environment with tight deadlines, and you are good at planning, coordinating and reaching consensus. You are thorough, structured and conscientious, and you have a good sense of humour.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous development.

Contact
For further information, please Contact Trine Kruse on + 45 3079 6107, Lisbet Westergaard on + 45 3079 9817 or Mette Pierri Stensler-Thomsen on + 45 3075 2575.

Deadline
10 January 2014

Medical Writing Specialist (Søborg, Denmark)

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Medical Writing Specialist

- Research & Development
- Denmark - Søborg

Clinical Reporting is looking for a medical writing specialist. You will be offered a challenging job with a significant amount of individual responsibility, and good personal development opportunities in an international and dynamic atmosphere.

About the Department
Clinical Reporting is the medical writing function at Novo Nordisk and is part of Global Development. We are currently 60+ employees, primarily medical writers and clinical publishers. We are a diverse group with different nationalities and professional backgrounds working together in a pleasant and informal atmosphere. We are responsible for preparing clinical documents for submission to regulatory authorities worldwide as well as abstracts and posters for scientific conferences and manuscripts to scientific journals.

The job
As medical writing specialist, your main tasks involve preparation of complex clinical documents within Novo Nordisk’s different therapy areas. Planning and coordination of activities in a cross-disciplinary setting is a central part of the job. Your main collaboration partners include clinicians, statisticians, regulatory affairs professionals, trial managers and data managers from Novo Nordisk headquarters and international affiliates.

Another important component of the job is mentoring and training of other medical writers, which requires the ability to provide constructive feedback. The medical writing specialist is also expected to drive sharing of better practices across projects/processes.

All documents are written in English and must comply with internal Novo Nordisk standard operating procedures as well as external guidelines.

Qualifications
You have a university degree within natural sciences (MD, M.Sc., M.Sc.Pharm. or equivalent) and ≥5 years of medical writing experience. In addition, you have a good understanding of the pharmaceutical industry, including clinical development and regulatory processes and requirements. Your professional skills also include statistics and scientific research methods, and you have experience with writing publications for scientific journals. You master written and spoken English at a professional level, and you have a flair for, and a genuine interest in scientific communication. In addition, you should be able to communicate in a reliable, professional and trustworthy manner. You are a strong team player who adapts easily to a changing environment with tight deadlines, and you are good at planning, coordinating, managing stakeholders and reaching consensus. You are thorough, structured and conscientious, and you have a good sense of humour.

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous development.

Contact
For further information, please Contact Trine Kruse on + 45 3079 6107, Lisbet Westergaard on + 45 3079 9817 or Mette Pierri Stensler-Thomsen on + 45 3075 2575

Deadline
10 January 2014

Engageret automatik ingeniør (Bagsværd, Danmark)

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Engageret automatik ingeniør

- Forskning og Udvikling
- Danmark - Bagsværd

CMC API Development har ca. 350 ansatte. Vi er ansvarlige for API fremstilling og proces-udvikling af nye API kandidater til alle Novo Nordisk udviklingsprodukter. Dette inkluderer områderne gæring, dyrkning, kemisk syntese, grovrens og finrens. Der er stor fokus på en stabil produktion og altid et stort antal spændende projekter i pipelinen. Vi søger derfor en selvstændig og dygtig automatik ingeniør med erfaring fra drift af proceskontrolsystemer, anlægs- og udstyrs kvalificering samt projektdeltagelse på større og mindre investerings-projekter i et GMP miljø.

Om afdelingen
Vi er en teknisk support afdeling og vores primære opgaver er at supportere og sikre stabil drift i vores pilot anlæg. Vi er ca. 40 personer organiseret i tre teams og dækker over mange faggrupper herunder: PCS, projekter og kvalificering, smede, elektrikere, kalibrering, SAP og anlægsteknikere. I teamet Technical Compliance and Automation løser vi en lang række opgaver i forbindelse med drift og vedligehold af automatik-systemer og står også for projektkoordinering af mindre anlægsopgaver.

Jobbet
Du bliver en del af et team på 8, hvor vi er 5 i automatikgruppen. Gruppen er meget dedikeret til at supportere vores kunder på tværs af alle pilot anlæg i Bagsværd. Din opgave er overordnet support på automatik, primært DeltaV. Kendskab til CTS/BMS er et plus. Det indebærer sikring af, at produktionssystemerne er i compliance med gældende regler, håndtering af daglig support, trouble shooting i kontrolrummet, hvor man i samarbejde med kemikere håndterer hændelser opstået i produktionen. Du skal være i stand at gennemføre ændrings- og kvalificeringsopgaver i samarbejde med vores kunder i anlæggene. Derudover kan du fra tid til anden blive involveret i vores investeringsprojekter.

For at løse dine opgaver i rette kvalitet og i rette tid kræver det, at du er dygtig til at prioritere og er i stand til at arbejde selvstændigt. Det forventes at du har evnen til at skabe gode relationer og dialog med både med dine kollegaer i afdelingen, samt operatører og kemikere i anlæggene, QA og vores eksterne leverandører. Du skal kunne stille de rette spørgsmål, vise interesse og udfordre holdninger og processer.

Du kan se frem til en afvekslende og til tider omskiftelig hverdag i et job, hvor det forventes, at du selv kan tage beslutninger og føre dem ud i livet.

Kvalifikationer
Du har gennemført en akademisk eller anden teknisk uddannelse og har en stærk interesse for automatik. Vi er underlagt store kvalitetskrav, så forståelse og kendskab til GMP, GAMP, ISA95/88 er et stort plus. Vi lægger vægt på at du har et godt humør og kan lide at tage fat i opgaverne, også når de ikke bliver lagt tilrette foran dig.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med mange gode kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vil du vide mere om stillingen, så kontakt Andreas Heuer på + 45 3079 8595.

Ansøgningsfrist
05. januar 2014

Laborant med celle og GMP erfaring - Vikar (Måløv, Danmark)

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Laborant med celle og GMP erfaring - Vikar

- Forskning og Udvikling
- Danmark - Måløv

Vil du være med til at udvikle og validere cellebaserede bioassays? Og har du lyst til at være en del af en åben, dynamisk og social gruppe med et stærkt fokus på faglige evner og løbende forbedringer? Så er du måske den nye kollega, vi leder efter.

Om afdelingen
De to Bioactivity teams er en del af afdeling 318, CMC Bioassay, som er placeret i CMC DP Development, R&D, Novo Nordisk A/S. Teamet er fysisk placeret i Måløv og kører i hverdagen som et team, bestående af 9 akademikere, 10 teknikere og en teamleder.

Jobbet
Du vil efter en oplæringsperiode deltage i udvikling af bioassays til projekter i alle klinisk forsøgsfaser. Du bliver ansvarlig for at modtage, analysere, beregne og afgive svar på analyseprøver i LIMS. Det forventes at du tager aktivt del i optimering af vores arbejdsgange i teamet, samt i udarbejdelsen af dokumenter. Du vil udover analysearbejdet også deltage i vores daglige driftsopgaver, som bl.a. indbefatter pasning af mammale cellekulturer og vedligeholdelse af apparatur. Arbejdet kræver en god ordenssans idet det foregår under GMP.

Kvalifikationer
Du er laborant eller tilsvarende og har erfaring med analysearbejde og håndtering af mammale cellekulturer. Du har kendskab til GMP og er glad for at arbejde i et team. Du har udover en god humoristisk sans og godt humør, en naturlig ordenssans, er systematisk, selvstændig, motiveret og kan holde hovedet koldt i travle perioder.

I Novo Nordisk skaber vi værdi ved sætte patienterne først. Hvert tiende sekund bliver to personer diagnosticeret med diabetes, og næsten 366 millioner mennesker i hele verden har brug for os. At arbejde her handler ikke bare om at tjene til føden, men om at gøre en forskel.

Kontakt
Vil du vide mere om stillingen så kontakt Pernille Hulgaard på +45 3075 0835 eller Jesper R. Jørgensen +45 3079 7885 (uge 52-01 undtaget).

Ansøgningsfrist
15. januar 2014

Student Assistant Epidemiology (Søborg, Denmark)

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Student Assistant Epidemiology

- Student and Internships
- Denmark - Søborg

Are you looking for a student assistant job with possibilities to make a difference personally and professionally? Do you thrive with working as a personal assistant? Are you dedicated to making the best possible effort?

About the department
The Department of Epidemiology is a department within Global Development, and focuses on contributing with epidemiological knowledge to various stakeholders in the Novo Nordisk organisation. As a student assistant in Epidemiology you will assist the team of 12 epidemiologists in analysing, validating, and communicating epidemiological knowledge.

The job
You will be involved in various projects incl. non-interventional post-marketing studies, and preparation of epidemiological reports to stakeholders. The tasks will include validation of data in abstracts and proofreading of publications, and preparation and validation of presentations. In addition updating the department website and assisting in literature reviews and data analyses.

Qualifications
You are studying a relevant BSc/MSc programme related to epidemiology, and you have preferably 2 years until graduation. You have a strong interest and understanding of epidemiology and biostatistics, are proficient in MS Office (especially Excel and PowerPoint), and are fluent in spoken and written English. Familiarity with SAS and PubMed is an asset.

You are dedicated, have excellent interpersonal skills, a good feeling for details, and have a positive mind-set.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.”

The position is located in Søborg and the working time is estimated to be 15 hours per week, but mutual flexibility is expected.

Contact
For further information, please contact Anne Louise Svendsen at +45 3075 2799 or Sofia Inez Iqbal Kring at +45 3075 5255.

Deadline
3 January 2014

Dygtige ledere til Novo Nordisk Kalundborg (Kalundborg, Danmark)

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Dygtige ledere til Novo Nordisk Kalundborg

Du kan lære mere om Novo Nordisk�s største produktionssite ved at bruge www.novonordisk.com/kalundborg-careers

- Produktion, Teamleder
- Danmark - Kalundborg

Brug dine GMP-evner i verdens største insulinproduktion

Novo Nordisk er verdens førende virksomhed inden for diabetesbehandling. Vores ambitioner og dygtige medarbejdere har bragt os meget langt. Og vi er slet ikke færdige. Derfor investerer vi massivt i hele vores værdikæde. Det gælder globalt og ikke mindst i vores produktions-setup. Vores fabrikker i Kalundborg er en hjørnesten i dette. Og det er her, du kommer ind i billedet.

Om afdelingen
Vores succes gør, at vi mangler dygtige teamledere med ledererfaring i en hel række teams i Kalundborg. Jobbene spænder bredt, og vi har derfor brug for profiler med forskellig erfaring og specialisering. Nogle skal lede akademiker-teams i business support-funktioner og andre skal lede teams i selve produktionen. Teamene er typisk på 8-20 medarbejdere.

Jobbet
De forskellige teams arbejder fx med processupport, QA, QC, projekter, EHS & IT, vedligehold eller logistik, planlægning, indkøb og økonomi m.m. Som teamleder er du en vigtig nøglefigur når du driver dit team og dermed Novo Nordisk frem til nye, store resultater. Med din positive og smittende energi får du dit team til at spille sammen, så I når selv de mål, I troede, var tæt på umulige. Du sætter retningen, inspirerer og vejleder dine medarbejdere, så de er klar over: hvad målene er, hvorfor deres indsats er så vigtig, og hvordan de arbejder smart og efter gældende regler og myndighedskrav.

I den sammenhæng driver du løbende optimeringer af vores systemer og processer ud fra vores LEAN-tankegang. Forandring til det bedre er således en helt central del af vores verden, og som leder går du forrest i at tænke nyt og hele tiden stræbe efter at blive bedre. Du bliver en del af afdelingens lederteam og er i tæt dialog med teamlederkolleger på tværs af afdelinger. Det er jeres ansvar at implementere Novo Nordisk’s strategi og værdier i afdelingen. Du kan se frem til et job, hvor du får mulighed for en stærk faglig, personlig og ledelsesmæssig udvikling.

Kvalifikationer
Du har en længerevarende uddannelse og konkret ledererfaring. Du kan derfor kombinere den nødvendige faglige indsigt med en åben og anerkendende ledelsesstil, som du bruger til at involvere og engagere dine medarbejdere. Samtidig har du gennemslagskraft og kan træffe og gennemføre selvstændige beslutninger. I forlængelse heraf trives du i en foranderlig kultur med ambitiøse målsætninger og høj grad af kompleksitet. Har du ikke arbejdet med LEAN, har du erfaring med systematisk optimering og problemløsning. Vil du arbejde i eller supporterende til produktionen, skal du have GMP/GxP erfaring fra et reguleret miljø underlagt høje kvalitetskrav.

Novo Nordisk i Kalundborg

Novo Nordisk PS Kalundborg er i sig selv en by i byen, kun godt en times kørsel fra København. Området er på størrelse med 270 fodboldbaner. Vi er 2.700 mennesker i alt fordelt på 15 fabrikker, og vi producerer ca. 50 % af verdens insulin. PS i Kalundborg kan helt kort sammenfattes til: udviklingsmuligheder uden ende. Skulle du have lyst til at flytte til Kalundborg, kommer du til en by tæt på skov og vand, med gode skoler, sports og fritidsfaciliteter og meget mere. Har du brug for det, har vi gode erfaringer med at hjælpe tilflyttere med at finde ny bolig. Besøg vores hjemmeside og læs mere om de forskellige job og PS Kalundborg.

Vi glæder os til at høre fra dig: novonordisk.com/kalundborg-careers

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med usædvanligt talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vil du vide mere om stillingerne, så kontakt Lili Behjat Kristensen på LBEK@novonordisk.com

Ansøgningsfrist
31. januar 2013

Senior International Trial Manager (Søborg, Denmark)

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Senior International Trial Manager

- Research & Development, Trial Manager
- Denmark - Søborg

Do you have extensive experience in driving global clinical trials and do you want to exert your influence by managing large global trials in Inflammation and Growth Hormone, including trials in Rheumatoid Arthritis (RA), Crohn’s Disease (CD), Systemic Lupus Erythematous (SLE), ulcerative colitis (UC) and Growth Hormone Deficiency disorders? Are you prepared to embrace and tackle constant changes as part of your work each day? Then we may have just the right job for you.

About the department
Inflammation & Growth Hormone is the newest therapeutic area in Novo Nordisk. In Clinical Operations, Inflammation & Growth Hormone, we are now approx. 40 employees and we continue to grow as the pipeline matures. We are responsible for the planning, conduct, and finalisation of clinical trials within Inflammation & GH. We collaborate globally, with CROs and to a growing extent, with our Novo Nordisk affiliates. We are characterised by a world-class team spirit and quality mind-set, by our change readiness and an open, trust-based and creative working environment. Our working environment is characterised by interesting and demanding assignments and continuous professional development opportunities.

The job
The job as Senior International Trial Manager demands that you are capable of directing and driving large global phase 2b/3 trials. You will be responsible for ensuring that project key deliverables are met in time, at a high quality and within budget. You will be chair of the international study group, for which you will plan and conduct team meetings with focus on stakeholder engagement, knowledge sharing and decision making. This includes vendor management of CROs participating in the trial execution. You will participate in and contribute to relevant investigator and monitor meetings.

The job requires that you apply a structured and analytical approach during development of relevant trial documents such as trial protocol, informed consent, recruitment strategies, risk analysis plans, communication plans and trial budgets. You are detail-oriented, while able to maintain overview, digest complex data and evaluate the adequate level of quality.

You are expected to be able to identify better practices and create improvements and you will be able to chair cross-project/cross-functional tasks forces. You may act as trainer across projects and mentor new staff.

Qualifications
You hold an academic degree within natural sciences or healthcare. You are a clear communicator and can inspire and motivate a team to deliver their best in an ever-changing environment. You have a strong knowledge of clinical trial planning and execution and a minimum of 5 years’ experience in managing large clinical trials.

You have a quality mind-set and know how to prioritise between different tasks in a dynamic environment which requires a high degree of flexibility. You work independently while also being a dedicated team player. You have excellent cross-cultural awareness and like to contribute to multi-cultural project groups. You are fluent in written and spoken English.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

You will be part of a successful, expanding company in which working is not just a way to make a living, but a way to make a difference.

Contact
For further information, please contact Louise Høyer at +45 3075 1535 or Marianne Willert at +45 3079 3277

Deadline
07 January 2014.

Laborant til laboratorieforsøg-produktion af HPLC-kolonner (Køge, Danmark)

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Laborant til laboratorieforsøg/produktion af HPLC-kolonner

- Produktion
- Danmark - Køge

Vil du samarbejde omkring stabile produktionsprocesser og levering af HPLC-kolonner og være en del af et team i udvikling med fokus på faglighed, engagement og quality mindset ? Du er positiv, engageret og fleksibel, og du trives med en omskiftelig hverdag, hvor fokus sættes ud fra kundernes behov. Vi har brug for din hjælp i en 9-10 måneders periode. Vi tilbyder en spændende arbejdsplads med skiftende udfordringer, hvor du kan opnå god erfaring med kolonneproduktion/stabilisering af produktionsprocesser. Arbejdet foregår i en uformel atmosfære, hvor vi har fokus på som team at levere i rette kvalitet til vores kunder.

Om afdelingen
FeF Chemicals A/S er et 100% ejet datterselskab af Novo Nordisk A/S og ligger i Køge. I dag er vores største produktgruppe substitueret kiselgel, der bruges til kromatografisk oprensning af Novo Nordisks lægemidler. Desuden producerer vi kvaternære ammoniumforbindelser, som vi markedsfører over hele verden. Vi er i dag ca. 140 ansatte i firmaet. Udviklingsafdelingen består af 6 kemikere og 12 laboranter fordelt på 3 teams. Vi er kompetencecenter for gelteknologi i Novo Nordisk, hvilket indebærer en tæt kontakt til forsknings-, udviklings- og produktionsafdelinger i koncernen.

Du bliver en del af Kolonnepak-teamet, som består af 3 laboranter, 3 kemikere og en teamleder.

Teamet producerer analytiske HPLC-kolonner til analyse af lægemidler og brug i udviklings-, produktionsudvikling- og analyseafdelinger i Novo Nordisk og FeF. For at stabilisere kolonneproduktionen gennemfører vi udviklingsprojekter, baseret på laboratorieforsøg. Vi fremstiller kromatografiske faser ved organisk syntese med kiselgel og producerer kolonner under ISO9001. Tungt fysisk arbejde kan forekomme. Såvel udvikling som produktion dokumenteres.

Jobbet
Arbejdet vil hovedsagelig bestå i at udføre og dokumentere laboratoriearbejde omkring levering af HPLC-kolonner og stabilisering af produktionsprocesser for kromatografiske geler og kolonnepakning.

Vi producerer, pakker og kvalitetskontrollerer kolonner. Du vil afhængig af erfaring komme til at udføre kemiske udviklingsforsøg med geler og kolonner/arbejde med forskellige produktionsprocesser og i mindre omfang kvalitetskontrol samt indgå i vedligehold og rengøring af udstyr. Du vil have kundekontakt, deltage i planlægning, dokumentere og håndtere ordrer, herunder udføre PC-arbejde.

Du vil opleve, at vi fokuserer på LEAN principper, og du vil kunne bidrage til at optimere vores arbejdsgange omkring kolonner.

Kvalifikationer
Du er uddannet (industri)laborant med erfaring indenfor HPLC-analyse og dokumentation (ISO/GMP). Det er en fordel, hvis du har kendskab til organisk syntese.

Du er god til at planlægge og organisere din arbejdsdag. Som person er du omhyggelig og samvittighedsfuld omkring udførelsen af dine arbejdsopgaver. Det er vigtigt, at du har en god ordenssans. Du skal være indstillet på at lære nye måder at gøre tingene på og være en engageret teamspiller, der gerne viser vejen i samarbejde med kollegerne.

Som person har du let ved at omgås kolleger på alle niveauer i organisationen, og du gør dit for at bidrage til den positive stemning i teamet. Du er selvstændig og tager styring over egne opgaver, og du trives med at løse opgaverne i tæt samarbejde med dine kolleger. Du tager ansvar for, at vi både som team og individer, når de mål forretningen har brug for. Du kan lide at optimere arbejdsgange og er god til at afslutte opgaver.

Hvis du er indstillet på at dokumentere levering af HPLC-kolonner og stabile produktionsprocesser, kan vi tilbyde dig samarbejde med kompetente og engagerede kolleger og mulighed for professionel og personlig udvikling.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med usædvanligt talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vi har brug for din hjælp i en 9-10 måneders periode. Vi tilbyder en spændende arbejdsplads med skiftende udfordringer, hvor du kan opnå god erfaring med kolonneproduktion/stabilisering af produktionsprocesser. Arbejdet foregår i en uformel atmosfære, hvor vi har fokus på som team at levere i rette kvalitet til vores kunder.

Vil du vide mere om stillingen, er du meget velkommen til at kontakte Kirsten Modvig på telefon på +45 2429 4119.

Ansøgningsfrist
6. januar 2014

Toxicologist position for Product Supply and Device support (Måløv, Denmark)

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Toxicologist position for Product Supply and Device support

- Research & Development
- Denmark - Måløv

A toxicologist position (Senior Scientist/Principal Scientist) is open for employment in the Department of Toxicology and Safety Pharmacology Diabetes, in Måløv from February 1st, 2014 or as soon as possible thereafter.

About the department
Apart from performing non-clinical studies supporting the safety assessment of drug candidates, the department is responsible for assessment of leachables from materials used in primary packaging, medical devices and manufacture process aids. Furthermore, we assist Product Supply with toxicological evaluations relevant for GMP processes. Our department is characterized by an open, innovative and ambitious atmosphere with good opportunities for further development of the employees.

The Job
You will join our toxicology group and be responsible for toxicological assessments of non-active chemicals. You will be searching for toxicity data in the scientific literature and requesting relevant in silico and in vitro studies from external contract partners. Your role will be to support your colleagues in non-clinical development, medical device development and product supply in writing toxicological assessments of excipients, impurities and leachables. You will be responsible for planning and reporting biological risk management activities of our exciting portfolio of medical device projects for submission to regulatory authorities in accordance with international standards and guidelines. Occasionally, you will work in international expert groups and represent Novo Nordisk at scientific conferences.

Qualifications
You have a degree in life- or pharmaceutical sciences combined with a good understanding of physiology and pathology. You have a professional background in toxicological risk assessment preferably with several years´ experience in medical devices, food packaging and/or industrial chemicals. We expect you to be familiar with current regulatory guidelines in the area and with searching for and interpretation of data from toxicological studies published in international scientific journals. Ideally you have a solid understanding of organic chemistry and understand basic principles of the biotechnological manufacture processes and drug development. We will take care of any necessary additional training, coaching and education. We expect that you are clear in your communication, possess excellent written and spoken English skills and focus on providing high-quality, timely results in close collaboration with your internal and external stakeholders.

At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.

Contact
For further information, please contact Ingrid Brück Bøgh at +45 3075 4515.

Deadline
16 January 2014.

Administrativ Teknikker til pilot produktion 12 mdr. vikariat (Gentofte, Danmark)

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Administrativ Teknikker til pilot produktion 12 mdr. vikariat

- Forskning og Udvikling
- Danmark - Gentofte

Vil du bidrage til en hurtig og effektiv produktion og frigivelse af lægemidler til kliniske studier? CS Aseptic Pilot Plant er fuldt booket af produktioner, og søger derfor snarest en engageret laborant til at sikre vi kan følge med (vikar 12 mdr).

Om afdelingen
Aseptisk Pilot Plant er en mindre produktionsenhed i CMC clinical supplies med cirka 65 ansatte i Måløv. Vi befinder os i grænsefladen mellem udvikling og produktion og har bred kontakt til mange funktioner i virksomheden. Vores primære opgave er at producere aseptisk fremstillede færdigvarer til brug i prækliniske og kliniske studier i forbindelse med virksomhedens udviklingsprojekter. Vi er ca. 15 personer i teamet (halvt teknikkere og halvt kemikere), der alle bidrager med proaktiv tankegang og selvstændigt planlægning af arbejdet. Vi tager gerne alle ansvar, og har stor respekt for hinandens kompetencer.

Jobbet
Du vil få ansvaret for flere af de skrivebordsopgaver, der er en del af produktion af lægemidler under aseptiske betingelser. Det vil blandt andet være gennemgang af vores batch dokumentation og koordinering af aktiviteter i forbindelse hermed. Derudover vil du få ansvaret for arkivering og også indgå i registrering af vores råvare og DP i vores IT systermer. Din rolle vil kræve samarbejde på tværs i hele afdelingen.

Kvalifikationer
Vi forventer, at du er uddannet laborant. Du har gerne erfaring med præparation af lægemidler under klassificerede forhold, og den tilhørende dokumentation. Du har viden om cGMP, god til detaljer og både lyst og evne til skriftligt arbejde. Du kommunikerer åbent og konstruktivt, er initiativrig, fleksibel og ansvarsbevidst. Du skal kunne bevare overblikket over mange opgaver på én gang i et til tider meget hektisk miljø.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der hjælper os med at forbedre mange menneskers liv. Til gengæld tilbyder vi dig muligheden for at arbejde sammen med usædvanligt talentfulde kolleger, og vi tilbyder dig en lang række muligheder for professionel og personlig udvikling.

Kontakt
Vil du vide mere om stillingen, så kontakt teamleder Lene Kragelund på tlf. 3079 3601.

Ansøgningsfrist
10 January 2014

Safety Medical Writer (Bagsværd, Denmark)

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Safety Medical Writer

- Quality
- Denmark - Bagsværd

Are you interested in drug safety and pharmacovigilance writing?” Do you want to be part of a department that keeps patients safe? Then we definitely want to hear from you!

About the department
Safety Surveillance Reporting is responsible for aggregate safety reporting on the surveillance of adverse reactions reported for marketed products and products under development at Novo Nordisk A/S. We are a dynamic, well-functioning, international team of 10 Safety Medical Writers and 6 Safety Publishers. We work together to coordinate, prepare, and electronically publish all key safety surveillance reporting documents. As we work in a rapidly changing regulatory landscape, where the global requirements for reporting on pharmacovigilance activities are still evolving, change-readiness and out-of-the-box thinking are both invaluable assets.

The Job
This is a permanent job as a Safety Medical Writer in Safety Surveillance Reporting at Novo Nordisk A/S. In this role, you will be responsible for planning and managing the process for document preparation in a cross-functional environment, soliciting relevant information from stakeholders for different areas across Novo Nordisk A/S, and being overall responsible for writing high quality documents. You will typically work in close collaboration with Safety Surveillance Advisors, Medical Specialists from Global Development, Medical Advisors from Medical Affairs, Project Managers from Regulatory Affairs, and Safety Publishers. While your key responsibilities will include preparing the key safety reporting documents (including Development Safety Update Reports, Periodic Safety Update Reports, and Clinical Risk Management Plans), you will also be expected to actively contribute to continual process improvements and other improvements projects.

Qualifications
You have a university degree (MD, PhD, MSc or equivalent) with a demonstrated a flair for, and genuine interest in scientific communication in English (publications or equivalent). Experience from the pharmaceutical industry and pharmacovigilance in particular, are a major advantage, but not a must. Strong project management and inter-personal skills are a pre-requisite for the role as Safety Medical Writer as co-ordinator and writer in the multi-disciplinary teams. You must be good at planning, coordinating, and reaching consensus. You are able to work independently, but at the same time you are a strong team player who adapts easily to a changing environment and tight deadlines. As all our documents are written in English, you must be fluent in both written and spoken English. Good attention to detail is important for reviewing documents, and for spotting important details amongst large volumes of data. You are thorough, structured and conscientious, and you have a good sense of humour. Experience with LEAN or similar is an advantage for contributing to continuous process improvement.

At Novo Nordisk A/S, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact
For further information, please contact Samuel Ramsden +45 3075 5727 or Terrie Ramirez +45 3079 7385.

Deadline
6 January 2014.

Erfarne produktionskemikere- -ingeniører (Kalundborg, Danmark)

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Erfarne produktionskemikere/ -ingeniører

Du kan lære mere om Novo Nordisk�s største produktionssite ved at bruge www.novonordisk.com/kalundborg-careers

- Produktion
- Danmark - Kalundborg

Brug dine GMP-evner i verdens største insulinproduktion i Kalundborg

Novo Nordisk er verdens førende virksomhed inden for diabetesbehandling. Vores ambitioner og dygtige medarbejdere har bragt os meget langt. Og vi er slet ikke færdige. Derfor investerer vi massivt i hele vores værdikæde. Det gælder globalt og ikke mindst i vores produktions-setup. Vores fabrikker i Kalundborg er en hjørnesten. Og det er her, du kommer ind i billedet. Lige nu mangler vi erfarne produktions­kemikere.

Om afdelingen
Vores succes gør, at vi mangler dygtige specialister med GMP-erfaring i en hel række produktionsteams i Kalundborg. Jobbene spænder bredt, og vi har derfor brug for profiler med forskellig erfaring og specialisering. Produktionen består af gæring, grovrens og finrens. Resultatet bliver en bred vifte af innovative insuliner til gavn for patienter over hele kloden.

Jobbet
Vi mangler produktionskemikere/-supportere, der kan bruge deres viden og erfaring til at gøre vores produktion så effektiv som overhovedet muligt, fordi den hviler på gennemtænkte og standardiserede processer og systemer. Procesoptimering baseret på vores LEAN-værktøjer løber således som en rød tråd på tværs af disse stillinger, hvor stort ansvar og indflydelse går hånd i hånd. Som kemiker/kemiingeniør/farmaceut kan du fx komme til at arbejde med at håndtere afvigelser, supportere og vejlede vores driftsoperatører, udføre kontrolanalyser, validering, systematisk problemløsning, dokumentation, projektarbejde m.m.

Dit mål er at bidrage til en stabil produktion i absolut topkvalitet og altid i overensstemmelse med gældende kvalitets- og GMP-regler. En helt afgørende del af dette er en standardiseret proces, og her spiller du en nøglerolle. Grundlæggende deler du din indsats mellem at håndtere afvigelser og arbejde på optimeringsprojekter. I begge roller bruger du meget tid på gulvet i produktionen for så at tage dine iagttagelser med til skrivebordet, hvor du udarbejder dokumentation. Jobbet giver dig et stærkt fundament for at fortsætte din karriere som fx projektleder på bl.a. optimeringsprojekter eller som leder – hvis du ønsker det.

Kvalifikationer
Du er kemiker, ingeniør, farmaceut eller lignende, og du har solid erfaring med procesanlæg og processtyring. Du er således vant til at arbejde efter systematiske kvalitetssystemer, og du er selv bannerfører for høj kvalitet. Det er helt naturligt for dig at tage ansvar for dine opgaver og nå dine deadlines. Samtidig er det afgørende, at du trives i et travlt miljø, der er i stadig forandring. Du kan derfor både prioritere mellem mange sideløbende opgaver og være med til at drive forandringer, der forbedrer. Da vi er mange involveret i processen på tværs af faggrupper, afhænger din succes i høj grad af din evne til at skabe og pleje relationer med mange forskellige mennesker – samt selvfølgelig din lyst til at arbejde målrettet for, at vi lykkes som et hold. Derudover skal du kunne begå dig på engelsk i skrift og tale.

I Novo Nordisk er det dine evner, dit engagement og dine ambitioner, der forbedrer mange menneskers liv – i samspil med usædvanligt talentfulde og passionerede kolleger.

Novo Nordisk i Kalundborg

Novo Nordisk PS Kalundborg er i sig selv en by i byen, kun godt en times kørsel fra København. Området er på størrelse med 270 fodboldbaner. Vi er 2.700 mennesker i alt fordelt på 15 fabrikker, og vi producerer ca. 50 % af verdens insulin. PS i Kalundborg kan helt kort sammenfattes til: udviklingsmuligheder uden ende. Skulle du have lyst til at flytte til Kalundborg, kommer du til en by tæt på skov og vand, med gode skoler, sports- og fritidsfaciliteter og meget mere. Har du brug for det, har vi gode erfaringer med at hjælpe tilflyttere med at finde ny bolig. Besøg vores hjemmeside og læs mere om de forskellige job og PS Kalundborg.

Vi glæder os til at høre fra dig: novonordisk.com/kalundborg-careers

Kontakt
Vil du vide mere om stillingen, så kontakt Jacob Dahl Nielsen på +45 3075 5486.

Ansøgningsfrist
31. januar 2014

Tekniske ingeniører (Kalundborg, Danmark)

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Tekniske ingeniører

Du kan lære mere om Novo Nordisk�s største produktionssite ved at bruge www.novonordisk.com/kalundborg-careers

- Produktion
- Danmark - Kalundborg

Brug dine GMP-evner i verdens største insulinproduktion i Kalundborg

Novo Nordisk er verdens førende virksomhed inden for diabetesbehandling. Vores ambitioner og dygtige medarbejdere har bragt os meget langt. Og vi er slet ikke færdige. Derfor investerer vi massivt i hele vores værdikæde. Det gælder globalt og ikke mindst i vores produktions-setup. Vores fabrikker i Kalundborg er en hjørnesten i dette. Og det er her, du kommer ind i billedet.

Om afdelingen
Vores succes gør, at vi mangler dygtige tekniske ingeniører i en række teams i Kalundborg. Du bliver del af et team, der har ansvar for den tekniske support til en produktionsenhed. Dit og kollegernes fokus er, at udstyret altid er i topform og compliance. Teamet er således en helt uundværlig del af arbejdet med at sikre en stabil og sikker produktion. Videndeling og stærkt teamwork er en naturlig del af vores hverdag, og vi kan love spændende udfordringer og masser af udvikling for dig personligt.

Jobbet
Dit grundlæggende fokus bliver at sikre compliance på vores produktions- og/eller utility-udstyr og herunder at bidrage til, at vi hele tiden forbedrer udstyret rent teknisk og dermed også gør det mere effektivt. Du kommer både til at arbejde med kravspecificering , kvalificering og eksekvering af forretningskritiske tekniske projekter. I dagligdagen vil nogle af dine vigtige opgaver blive systematisk problemløsning baseret på vores LEAN-værktøjer, håndtering af hændelser/afvigelser og ændringssager og udarbejdelse af operationelle dokumenter. Du spiller også en vigtig rolle i arbejdet med at sikre det rette vedligeholdelsesomfang. Som teknisk ekspert får du derudover ansvar for at håndtere kontrakter med både interne og eksterne leverandører.

Kvalifikationer
Du har teknisk baggrund som ingeniør eller tilsvarende suppleret med viden inden for fermentering, oprensning, utility og/eller autoklaver. Skal du have succes, skal du arbejde systematisk og analytisk og kunne bevare overblikket, når du arbejder på flere sideløbende opgaver/projekter samtidigt – og dermed også levere inden for de aftalte deadlines. Det er ligeledes vigtigt, at du trives med at arbejde i et super dynamisk miljø, der er i stadig forandring. Det kræver evnen til at møde kollegerne og opgaverne med en positiv indstilling og tro på, at bag ethvert problem gemmer sig en løsning, som du nok skal finde. Det er en forudsætning for at søge, at du er god til dansk i skrift og tale. Derudover skal du være god til engelsk.

I Novo Nordisk stræber vi efter at være de bedste. Vi er førende i verden indenfor diabetesbehandling og en større spiller indenfor behandling af blødninger, behandling med væksthormon og behandling med hormonterapi. Derfor kan vi tilbyde vores medarbejdere mulighed for en stærk professionel udvikling.

Novo Nordisk i Kalundborg

Novo Nordisk PS Kalundborg er i sig selv en by i byen, kun godt en times kørsel fra København. Området er på størrelse med 270 fodboldbaner. Vi er 2.700 mennesker i alt fordelt på 15 fabrikker, og vi producerer ca. 50 % af verdens insulin. PS i Kalundborg kan helt kort sammenfattes til: udviklingsmuligheder uden ende. Skulle du have lyst til at flytte til Kalundborg, kommer du til en by tæt på skov og vand, med gode skoler, sports- og fritidsfaciliteter og meget mere. Har du brug for det, har vi gode erfaringer med at hjælpe tilflyttere med at finde ny bolig. Besøg vores hjemmeside og læs mere om de forskellige job og PS Kalundborg.

Vi glæder os til at høre fra dig: novonordisk.com/kalundborg-careers

Kontakt
Vil du vide mere om stillingen, så kontakt Jacob Dahl Nielsen på +45 3075 5486.

Ansøgningsfrist
31. januar 2014

Programmers for clinical development (Søborg, Denmark)

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Programmers for clinical development

- Research & Development
- Denmark - Søborg

Are you interested in working with biological data and would you like to be part of a future with a strong pipeline of products, which ensures huge variety of tasks, great opportunities for individual development and influence on decision making?

Do you wish to work in a highly professional, engaged and global environment, where you can use your programming skills and quality mindset bringing clinical projects to registration and market? You may be one of our new statistical programmers.

About the department
The Biostatistics function is growing and consists currently of 150 statisticians and statistical programmers globally in our R&D clinical development organisation. Biostatistics is a dynamic department which cooperates with many different areas in the organisation both within Denmark and across borders with our affiliates in the US, India, China and Japan, as well as our outsourcing partners in India. Biostatistics provides a strong scientific community and we are organised in smaller units for each clinical project to ensure close collaboration with our various stakeholders.

The job
As statistical programmer your primary responsibility is to develop SAS programs based on clinical data for reporting of clinical trials, preparing summary documents and publications as well as supporting regulatory commitments. You handle many assignments concurrently and will work in close collaboration with a team of statisticians and statistical programmers.

You will be involved in coordinating and supervising the work of contract houses around the world performing outsourced programming tasks. Therefore we expect you to communicate programming/technical problems and ideas both internally and externally, as well as coach more junior colleagues. You must take responsibility for both standard tasks and more complex and time critical tasks.

Development of methods and processes, as well as knowledge sharing is continuously on-going in Novo Nordisk, especially based on the initiative of the employees. We expect you to take part in the maintenance of Biostatistics as a good and challenging place to work. In exchange we of course offer great opportunities for on-going training to ensure the continued competency development of our employees.

Qualifications
You have a B.Sc. or M.Sc. within science, IT or other relevant degree, extensive knowledge and experience with the SAS programming language, as well as preferably experience within clinical research. You are able to write efficient, well documented and standardised computer programs. Furthermore, strong cooperation and analytical skills as well as an understanding for data structure are a necessity. You are capable of working independently, take on responsibility and show initiative.

We expect you to be independent and that you are flexible and efficient. In addition we expect you to be able to overview several challenging tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast. Experience with project management will be an advantage.

Good collaboration and communication skills are necessary characteristics. You are also fluent in English.

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.

Contact
For further information, please contact Lise Voss Skotner at +45 3079 4474 or Trine Næstoft at +45 3075 2135.

Deadline
12 January 2014.

Programmers for clinical development (Aalborg, Denmark)

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Programmers for clinical development

- Research & Development
- Denmark - Aalborg

Are you interested in working with biological data and would you like to be part of a future with a strong pipeline of products, which ensures huge variety of tasks, great opportunities for individual development and influence on decision making?

Do you wish to work in a highly professional, engaged and global environment, where you can use your programming skills and quality mindset bringing clinical projects to registration and market? You may be one of our new statistical programmers.

About the department
The Biostatistics function is growing and consists currently of 150 statisticians and statistical programmers globally in our R&D clinical development organisation. Biostatistics is a dynamic department which cooperates with many different areas in the organisation both within Denmark and across borders with our affiliates in the US, India, China and Japan, as well as our outsourcing partners in India. Biostatistics provides a strong scientific community and we are organised in smaller units for each clinical project to ensure close collaboration with our various stakeholders.

The job
As statistical programmer your primary responsibility is to develop SAS programs based on clinical data for reporting of clinical trials, preparing summary documents and publications as well as supporting regulatory commitments. You handle many assignments concurrently and will work in close collaboration with a team of statisticians and statistical programmers.

You will be involved in coordinating and supervising the work of contract houses around the world performing outsourced programming tasks. Therefore we expect you to communicate programming/technical problems and ideas both internally and externally, as well as coach more junior colleagues. You must take responsibility for both standard tasks and more complex and time critical tasks.

Development of methods and processes, as well as knowledge sharing is continuously on-going in Novo Nordisk, especially based on the initiative of the employees. We expect you to take part in the maintenance of Biostatistics as a good and challenging place to work. In exchange we of course offer great opportunities for on-going training to ensure the continued competency development of our employees.

Qualifications
You have a B.Sc. or M.Sc. within science, IT or other relevant degree, extensive knowledge and experience with the SAS programming language, as well as preferably experience within clinical research. You are able to write efficient, well documented and standardised computer programs. Furthermore, strong cooperation and analytical skills as well as an understanding for data structure are a necessity. You are capable of working independently, take on responsibility and show initiative.

We expect you to be independent and that you are flexible and efficient. In addition we expect you to be able to overview several challenging tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast. Experience with project management will be an advantage.

Good collaboration and communication skills are necessary characteristics. You are also fluent in English.

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.

Contact
For further information, please contact Malene Højbjerre at +45 3079 6209.

Deadline
12 January 2014

Statisticians for clinical development (Aalborg, Denmark)

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Statisticians for clinical development

- Research & Development
- Denmark - Aalborg

Are you interested in working with biological data and would you like to be part of a future with a strong pipeline of products, which ensures huge variety of tasks, great opportunities for individual development and influence on decision making?

Do you wish to work in a highly professional, engaged and global environment where you can use your statistical skills and quality mindset bringing clinical projects to registration and market? You may be one of our new statisticians.

About the department
The Biostatistics function is growing and consists currently of 150 statisticians and statistical programmers globally in our R&D clinical development organisation. Biostatistics is a dynamic department which cooperates with many different areas in the organisation both within Denmark and across borders with our affiliates in the US, India, China and Japan, as well as our outsourcing partners in India.

Novo Nordisk has a broad R&D pipeline and most of our statistical work is done in-house, thus we offer a wide variety of statistical challenges. Biostatistics provides a strong scientific community and we are organised in smaller units for each clinical project to ensure close collaboration with our various stakeholders.

The job
As statistician you are responsible for planning and coordinating time critical statistical tasks. You can be involved in a wide range of statistical assignments, such as providing input to clinical development plans, clinical trial protocols, summary documents and publications. Furthermore, you present and provide statistical interpretation of results, both internally and externally. You handle many assignments concurrently and will work in close collaboration with a team of statisticians and statistical programmers.

You will interact in cross disciplinary development teams across country borders and communicate statistical issues and ideas to non-statisticians. You can be involved in coaching of more junior colleagues and be responsible for coordinating and supervising the work of contract houses around the world performing outsourced tasks. Therefore we expect you to be able to communicate statistical problems and ideas clearly.

Development of methods and processes, as well as knowledge sharing is continuously on-going in Novo Nordisk, especially based on the initiative of the employees. We expect you to take part in the maintenance of Biostatistics as a good and challenging place to work. In exchange we of course offer great opportunities for on-going training to ensure the continued competency development of our employees.

Qualifications
You have a solid theoretical background in statistics corresponding to MSc level and experience within clinical research. You have experience with practical applications of biostatistical methodology and statistical software including SAS.

You work independently, take on responsibility and show initiative. You are flexible and efficient and able to handle several challenging tasks in parallel without compromising the quality of your work. We expect that you remain high spirited, also when things are moving fast. Experience with project management is an advantage.

You have good collaboration and communication skills and are fluent in English.

At Novo Nordisk we use our skills, dedication and ambition to improve treatment outcomes for people with diabetes and other chronic diseases. By working with us you will have the opportunity to do the same in a global business environment.

Contact
For further information, please contact Malene Højbjerre at +45 3079 6209.

Deadline
12 January 2014.

Statisticians for clinical development (Søborg, Denmark)

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Statisticians for clinical development

- Research & Development
- Denmark - Søborg

Are you interested in working with biological data and would you like to be part of a future with a strong pipeline of products, which ensures huge variety of tasks, great opportunities for individual development and influence on decision making?

Do you wish to work in a highly professional, engaged and global environment where you can use your statistical skills and quality mindset bringing clinical projects to registration and market? You may be one of our new statisticians.

About the department
The Biostatistics function is growing and consists currently of 150 statisticians and statistical programmers globally in our R&D clinical development organisation. Biostatistics is a dynamic department which cooperates with many different areas in the organisation both within Denmark and across borders with our affiliates in the US, India, China and Japan, as well as our outsourcing partners in India.

Novo Nordisk has a broad R&D pipeline and most of our statistical work is done in-house, thus we offer a wide variety of statistical challenges. Biostatistics provides a strong scientific community and we are organised in smaller units for each clinical project to ensure close collaboration with our various stakeholders.

The job
As statistician you are responsible for planning and coordinating time critical statistical tasks. You can be involved in a wide range of statistical assignments, such as providing input to clinical development plans, clinical trial protocols, summary documents and publications. Furthermore, you present and provide statistical interpretation of results, both internally and externally. You handle many assignments concurrently and will work in close collaboration with a team of statisticians and statistical programmers.

You will interact in cross disciplinary development teams across country borders and communicate statistical issues and ideas to non-statisticians. You can be involved in coaching of more junior colleagues and be responsible for coordinating and supervising the work of contract houses around the world performing outsourced tasks. Therefore we expect you to be able to communicate statistical problems and ideas clearly.

Development of methods and processes, as well as knowledge sharing is continuously on-going in Novo Nordisk, especially based on the initiative of the employees. We expect you to take part in the maintenance of Biostatistics as a good and challenging place to work. In exchange we of course offer great opportunities for on-going training to ensure the continued competency development of our employees.

Qualifications
You have a solid theoretical background in statistics corresponding to MSc level and experience within clinical research. You have experience with practical applications of biostatistical methodology and statistical software including SAS.

You work independently, take on responsibility and show initiative. You are flexible and efficient and able to handle several challenging tasks in parallel without compromising the quality of your work. We expect that you remain high spirited, also when things are moving fast. Experience with project management is an advantage.

You have good collaboration and communication skills and are fluent in English.

At Novo Nordisk we use our skills, dedication and ambition to improve treatment outcomes for people with diabetes and other chronic diseases. By working with us you will have the opportunity to do the same in a global business environment.

Contact
For further information, please contact Lise Voss Skotner at +45 3079 4474 or Trine Næstoft at +45 3075 2135.

Deadline
12 January 2014

Department cLean (Hillerød, Denmark)

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Department cLean

- Production
- Denmark - Hillerød

Are you strong at facilitation, coaching, process optimization, problem solving and eager to create continuous improvements in a dynamic organisation?

This may be your chance to play a key role in supporting a management team with a strong and very ambitious cLEAN® mindset in Device Manufacturing & Sourcing in Hillerød. Here you can look forward to being challenged, having personal influence in the organisation, as well as the opportunity for personal and professionaldevelopment.

About the department
You will be part of the Moulding Production Department, which has global responsibility of delivering plastic components for Novo Nordisk injection pens. We value professionalism and responsibility, and have an open and informal team culture. We ensure an environment, where we focus on continuously improving individual and team competences. You will interact in teamwork with your colleagues, and have a broad list of contacts throughout the organization.

The job
As Department Clean, you are a member of the management team, and will coach its members. Your overall objective is to bring cLEAN® thinking into all our systems, processes and methods. In other words you will contribute to making cLEAN® a natural way of thinking and acting for all employees in Moulding Production Department. You ensure that they are equipped with the right Clean tools to work as efficiently and cost-consciously as possible. In particular, your tasks will include from updating performance boards and KPIs, supporting the managers in identification of relevant areas of improvement through for example data analysis. You will also organise operational training in the training standards and drive workshops within the department. Lastly, you will get the chance to prepare and implement improvement projects and contribute to developing the processes on an ongoing basis. All in all, you will have a significant impact on our processes within the Moulding Production department.

Qualifications
You have a relevant degree at master’s level, ideally you have combined it with a couple of years’ hands on cLEAN® experience, from a job in which you have created measurable results. As such, you have a strong foundation combining LEAN theory and practical know how and you are fully capable of driving and engaging others in continuous improvement projects from a-z. . You have experience in planning and facilitating workshops and can create change through others

As a person, you are comfortable operating in a changing and dynamic environment and are able to establish relations to and cooperate with a wide variety of stakeholders. Your personal qualities define you as robust, empathetic and a self-starter with a high level of energy. Moreover, you have strong communication skills and master the discipline of giving presentations. Last but not least, you have proficiency in written and spoken English

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Rasmus Jørgensen +45 3075 3047.

Deadline
12 January 2014.

Sr. QA Professional (Måløv, Denmark)

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Sr. QA Professional

- Quality
- Denmark - Måløv

Are you looking for new challenges within QA – development of tablets for clinical trials and do you want to make a difference? The project portfolio is increasing, and therefore we are looking for a dedicated, professional and enthusiastic new colleague.

About the department
In CMC OPF QA we have the responsibility for quality assurance of oral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility of the oral pilot production. The department is recently established to support the development of oral protein formulations in our stakeholder departments.

The job
The job is very varied and challenging. In close cooperation with your 10 colleagues in QA, you act as a consultant for our pilot and formulation departments. You will act as qualified person delegate, and you will have the overview of process within development and production of tablets. The job is a combination of development project and facility related QA tasks in a complex and changing environment. You will approve documentation for development, manufacturing, stability, and QP release of drug product for clinical trials. You will assure that the development documentation is compliant with internal and external requirements.

You will approve facility related documentation needed for the operation of the oral pilot plant.

CMC Supply’s continuing high level of audit and inspection readiness is on top on your agenda.

In CMC Supply QA we work with QA oversight where you proactive together with your colleagues will identify areas where our stakeholders’ compliance can be strengthened.

You have a risk based approach to the development process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.

Qualifications
Ideally, you have a master in Pharmacy or corresponding qualifications and at least 3-5 years of experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: experience from tablet manufacturing/development, GMP, validation/qualification, requirements for tablet production, and requirements for investigational medicinal products for use in clinical trials.

You enjoy working in a dynamic environment, where teamwork is at the top of the agenda. Also, you are quite adaptable and challenge our way of doing things, so that we will get even better. You focus on results and quality – and contribute to the right level of compliance.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information please contact Janne Lavritsen +45 3075 7333.

Deadline
5 January 2014

Engineer, Chemist or Pharmacist for primary packaging (Hillerød, Denmark)

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Engineer, Chemist or Pharmacist for primary packaging

- Research & Development
- Denmark - Hillerød

Are you ready for a job where you combine your knowledge of materials, processes, suppliers and regulatory requirements? If so, this position as Primary Packaging Engineer could be your chance to have a key role at Novo Nordisk and build a career among specialists.

About the department
You will be part of the Primary Packaging department in Hillerød. We are part of R&D in Novo Nordisk, and we select primary packaging for direct contact with new pharmaceuticals. Further, we establish and maintain specifications for primary packaging.

The job
You select primary packaging to bring new pharmaceutical products to market. Moreover, you establish and maintain specifications and make sure that we are in regulatory compliance worldwide. In your daily work you will talk to stakeholders and in this way gather requirements to the packaging components. Moreover, you write specifications, ensure testing to verify performance of the components and ensure that everything is correctly documented. You will be in close dialogue with a large number of colleagues in R&D, Quality Assurance, Chemistry, Manufacturing & Control (CMC) and our production units across the world. In addition, you will give advice to device development in Device R&D, handle complaints and non-conformities and deal with day-to-day challenges.

Qualifications
You are a Chemical Engineer, Chemist or Pharmacist by training. Furthermore, you have some years of experience with primary packaging for pharmaceuticals, food or medical devices, or you have experience from a pharmaceutical production. If you have knowledge of GMP, quality assurance as well as plastic, rubber and glass, it will be an asset. You have a curious mindset and are eager to find the best solution. Your written and spoken English is at negotiation level, and there is no question in your mind that correct documentation is an indisputable activity in this job. Lastly, you take ownership of your assignments, secure buy-in from the involved stakeholders and have a structured way of working.

At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life.

Contact
For further information, please contact Lasse Wengel Christoffersen at +45 3075 3567.

Deadline
1 January 2014.
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