Clinical Supply Manager

Clinical Supply Manager


KLIFO is looking for a Clinical Supply Manager for our Glostrup office

Would you like to use your solid experience within the pharmaceutical industry to join our highly skilled Clinical supply department as Clinical Supply Manager? 

We are growing and we need more dedicated colleagues to help us maintain and further develop our high quality level to meet our clients and own requirements. 

The position:

As Clinical Supply Manager you will be working with a diversity of tasks from planning and coordinating clinical trials in close dialogue and cooperation with our clients. Preparation and approval of labels texts according to Annex 13, packaging materials, designs and blinding setups, coordinating return & destruction of IMP and cooperate with our distribution team in preparing distribution set ups. 

You will also coordinate and collaborate with other CMO/CRO’s and ensuring a very highly quality level.

Qualifications:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs. Also, the person must have an independent, positive, proactive and flexible personality. Our candidate is experienced with GMP and experienced within the pharmaceutical industry.

We offer:

As our new Clinical Supply Manager you will be part of an inspiring working environment in a growing company. You will work with exciting customers among competent colleagues where your knowledge, experience and contribution is valuable and highly appreciated. 

  • High job variation 
  • High level of influence
  • Great social working environment and commited colleagues
  • A highly flexible, free and trustful culture 

Location:

KLIFO has offices in both Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark. 

Contact:

For more information, please contact Lotte Harreby, Director at +45 44 222 969 or Pernille Smith, Team Manager at +45 44 222 986 

Applications should be sent to:

moc.ofilk@boj marked Clinical Supply Manager. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: 09 June 2022 (although applications are reviewed on an ongoing basis) 

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Business Controller

Business Controller


KLIFO is looking for a Business Controller for our Glostrup office

Are you a talented Business Controller looking for great colleagues?

KLIFO has grown significantly over the last years both in Denmark and through subsidiaries in Germany, Netherlands and Sweden. To support the growth, KLIFO is now looking for a dedicated Business Controller, who can be a pro-active support for the management primarily of the service area Clinical Operations Solutions. The service area is well-established in all countries and you will work closely together with management and project managers across the organisation.

The position as Business Controller:

The position includes many aspects and you thrive just as well with daily hands-on work as with analysis on future business. You will be sparring on financial topics with management, work with project controlling, prepare monthly reporting, forecasts, budgets and take care of the monthly invoicing in collaboration with project managers.

You will report directly to KLIFO’s CFO and you will work closely with management of the service areas. Further, you will have collaboration with the controllers working for the other service areas and with accounting. Together with a team of highly skilled finance colleagues you will also be involved in development of BI and Navision upgrade.

Your primary tasks will be:

  • Acting as a strong business partner to the service area management and project managers
  • Controlling and continuously having a financial overview of projects and contracts
  • Prepare estimates in collaboration with management
  • Prepare Monthly reporting including analysis, comments and closing process/invoicing
  • Prepare estimates and budgets
  • Enable decision-making through Analysis, BI, presentations and xls models.

Qualifications:

  • You have experience as Business controller preferably in a project-based organization
  • A relevant education such as cand. merc or HD
  • You thrive in a growing organization
  • You are able to handle complex information, maintaining a financial overview and you communicate clearly
  • You are used to work independently, and are a dedicated team player who values collaboration
  • You are an experienced strong user of Excel and BI and preferable you have experience with Dynamics Nav
  • You are fluent in Danish and in English

We offer:

KLIFO offers you an exciting position in a growing company where you will have the opportunity to influence decisions and develop your competences in collaboration with dedicated colleagues. This is your opportunity to work in an interactive, flexible and positive working environment with a high level of trust, transparency and cooperation across the company.

Location:

KLIFO has offices in both Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact CFO Jesper Lykkeberg, 44 123 263.

Applications should be sent to:

moc.ofilk@boj marked; “Business Controller”. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 27. May 2022. We review applications and invite for interviews on an ongoing basis. 

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Senior Pharmacovigilance Specialist

Senior Pharmacovigilance Specialist


KLIFO is looking for a talented and committed Senior Pharmacovigilance Specialist based in Denmark

We are looking for an additional Pharmacovigilance Specialist to join a dynamic and experienced team within Pharmacovigilance Solutions.

The people we want to engage like to work in an advisory role and have a positive, proactive, self-driven and self-confident personality. We offer a highly flexible, free and trustful working climate with competent colleagues, exciting customers and challenging projects.  

As our Senior PV Specialist:

You are responsible for all aspects of pharmacovigilance in your own projects including management, planning, PV set-up, execution, monitoring and documentation. 

You will:

  • Create trial specific Safety Management and SAE flow
  • Handle the safety database (not necessarily the technical part)
  • Ensure expedited reporting  to Competent Authorities and Ethic Committees/Independent Review Board
  • Review and present safety data listings (coding, signals)
  • Write and submit periodic reports 
  • Define Reference Safety Information
  • Review documents for safety information 
  • Lead or participate in safety oversight committees

Your qualifications as Senior PV Specialist:

  • MSc/BSc in the life sciences field and a minimum of 8-10 years of experience in a similar position in the pharmaceutical industry/Biotech/CRO
  • Experience within pharmacovigilance from both clinical and post-marketing phases
  • In-depth knowledge of international PV guidelines and regulatory requirements
  • Knowledge with device pharmacovigilance is an advantage
  • Experience with safety databases and knowledge of MedDRA and ATC coding
  • Excellent communication skills in English both written and verbal 
  • Master Microsoft Office
  • Able to translate client’s needs into solid deliveries

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • A heterogeneous client pool (pharmaceutical companies, established biotech, newly started biotech and academia)
  • Build international client relations
  • A unique opportunity to elaborate your competences and experience 
  • An interactive, flexible, trustful and positive working environment

Location:

KLIFO has offices in both Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Randi Rahbæk, Senior Clinical Research Director, at +45 4477 8704.

Applications should be sent to:

moc.ofilk@boj marked Senior PV Specialist. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 5 August 2022. Applications will be reviewed on an ongoing basis. 

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Warehouse Coordinator

Warehouse Coordinator


KLIFO søger en Warehouse Coordinator til lageret i Glostrup

Brænder du for at bruge dine erfaringer og dine kompetencer fra den farmaceutiske industri i en stilling som warehouse coordinator sammen med vores kompetente lagerteam? KLIFO ekspanderer hastigt og har brug for flere dedikerede kolleger, til at imødekomme kundebehov og fortsat udvikle og bidrage til KLIFO kvalitetskrav. 

Stillingen som Warehouse Coordinator:

Som Warehouse Coordinator vil du sammen med de nuværende medarbejdere stå for varemodtagelse af produkter og materialer, registrering af returmedicin, fremtagning og nedpakning af produkter til distribution samt forefaldende arbejde. Du vil begå dig i et team, hvor der er travlt, men samtidigt højt til loftet. 

Kvalifikationer som Warehouse Coordinator:

Som Warehouse Coordinator skal du kunne trives i en travl og flexibel hverdag. Du må gerne have erfaring fra lignende stilling i den farmaceutiske industri, men dog ikke et krav.

Du må gerne have en indgående erfaring indenfor GMP området. Du skal kunne skrive og tale flydende dansk samt engelsk til arbejdsformål. Sidst men ikke mindst skal du kunne indgå i et stærkt team samtidig med at være stabil og have struktur i dit arbejde.

Vi tilbyder:

Et inspirerende og motiverende arbejdsmiljø i en virksomhed i vækst og med mange spændende og forskelligartede opgaver. Du har som Warehouse Coordinator stor indflydelse på det daglige arbejde og nye ideér til indkomne opgaver. Arbejdstiden ligger i dagstimerne i hverdagene. Der tilbydes løn i henhold til kvalifikationer. 

Lokationer:

KLIFO har kontorer i Danmark, Tyskland, Sverige og Holland. Denne stilling er på vores facilitet i Glostrup, Danmark.

Kontakt:

For mere information, kontakt venligst Johan Pedersen, Team Manager, mobil 44 77 87 35 eller moc.ofilk@nesredeP.nahoJ. 

Ansøgninger skal sendes til:

moc.ofilk@boj mrk. Warehouse Coordinator. 

KLIFO håndterer ansøgningen og al relateret person data specifikt for dette jobopslag. Al personlig data håndteres konfidentielt jvnf. persondataforordningen (GDPR). 

Ansøgningsfrist: 15. maj 2022 

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QA Specialist/Senior QA Specialist, GCP and GVP

QA Specialist/Senior QA Specialist, GCP and GVP


KLIFO is looking for QA Specialist/Senior QA Specialist, GCP and GVP for our Glostrup office

 

The position as QA Specialist/Senior QA Specialist:

We are a growing QA department where we need a new colleague with competencies regarding GCP and GVP. GLP experience will be a benefit. The job will be a mixture of internal and external QA activities.

The external activities can be:

  • QA consulting to Clients
  • Provide various QA services to Clients. E.g.:
    • Develop or update QMS system
    • GAP analysis
    • Help to become Inspection ready
  • Performing worldwide Client Audits

The internal tasks will mainly be: 

  • Maintain the Quality Management System within the Clinical Area 
  • Perform Training within the Clinical area 
  • Ensure execution of the Clinical audit program 
  • Participate in KLIFO projects as QA representative 
  • Beside the above activities, be responsible for KLIFOs GDPR compliance review program. 

The qualifications of the QA Specialist/Senior QA Specialist:

You are MSc in the life science field and the ideal candidate for the position is a trained lead auditor with at least 7 years of QA experience within GCP and GVP in the pharmaceutical industry. GLP QA and GLP auditing experience is considered a benefit. 

You must be flexible and service-minded, a team player but also thrive working as a consultant and be capable of taking on a varity of different tasks and make decisions on your own. 

Willingness to work from client sites, when required and to travel to the extend necessary. 

Fluent in one of the Scandinavien languages and in English. 

We offer:

  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Join a team of experienced colleagues where you use and elaborate your skills and competences. 
  • Work in an dynamic, flexible and positive working environment in a rapidly developing company. 
  • You will experience a high-level of transparency and influence 

Location:

KLIFO has offices in both Denmark, Germany, Sweden and the Netherlands. This position is located at our office in Glostrup, Denmark. 

Contact:

For more information, please contact Anne Ploug Jørgensen, Director, QA, mobile phone, +45 44 222 982. 

Applications should be sent to:

moc.ofilk@boj marked QA Specialist/Senior QA Specialist GCP and GVP.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: Recruitment interviews will be held on an ongoing basis. 

View job post as a PDF.


Medical Writer

Medical Writer


KLIFO is looking for a talented Medical Writer in DK, SE or DE

KLIFO is expanding and wants to engage a Medical Writer into a dynamic and experienced team within Clinical Operations Solutions. The right candidate can be located in the Danish, Swedish or German office. 

The person we want to engage strive to work in a consulting environment and has a positive, proactive, flexible and self-driven personality. We offer a highly flexible, free and trustful working climate with exciting customers and challenging projects among competent colleagues.

The position as Medical Writer:

The MW is responsible for creation of medical and scientific documents and the factual and formally correct display of scientific results and findings within clinical trials and non-interventional studies according to the FDA/EMA and ICH guidelines, i.e.:

  • Writing of clinical study protocols
  • Generation of clinical study reports
  • Generation of IBs and other documents related to the conduct of clinical trials and non-interventional studies
  • Generation of patient facing material, e.g. patient information
  • Support the project team in preparation and compilation of narrative safety reports
  • Advise the project team in preparation of study documents

Furthermore, the MW will generate or contribute to the generation of regulatory documents, i.e.:

  • Briefing documents for authority meetings (primarily EMA, FDA and national EU authorities)
  • Orphan Drug Designation Applications (EU and US) 
  • Paediatric Investigation Plans/Pediatric Study Plans (EU/US)
  • General Investigational Plans (US)
  • Fast Track Designation Requests (US)
  • Break-through Designation Requests (US)
  • Non-clinical and clinical overviews and summaries for Module 2 (IND, MAA, NDA and BLA)

The qualifications of the Medical Writer:

  • MSc in the life sciences field or related discipline, preferable with a PhD and a minimum of 3 years in a similar position in the pharmaceutical industry/CRO
  • Experience in medical writing, particularly in the creation of Clinical Study Protocols/Clinical Study Reports conforming to ICH-GCP and writing of documents for EMA/FDA submissions
  • Good statistical understanding in the area of descriptive statistics
  • Ability to reproduce scientific data and complex issues accurately and in an understandable form
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into writing
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English
  • Microsoft Office Skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • A heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia) 
  • Build international client relations 
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment 

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. This position can be based in Denmark, Sweden or Germany.

Contact:

For more information, please contact Team Manager Stefan Ingelsson at +45 9189 4818 or moc.ofilk@nosslegnI.nafetS or Director Jennie Wilborgsson at +45 9363 8820 or moc.ofilk@nossgrobliW.einneJ

Applications should be sent to: 

moc.ofilk@boj, marked MW. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 31 May 2022 (although applications are reviewed on an ongoing basis).

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Senior CMC Expert/Project Manager

Senior CMC Expert/Project Manager


KLIFO is looking for a Senior CMC Expert/Project Manager for our Glostrup office

Would you like to use your CMC experience to support KLIFO’s increasing number of biotech and pharma clients progressing their drug development projects?

Then a permanent position acting as a consultant as part of our CMC team might be just the job for you. We’re looking for a new colleague to become part of our highly experienced CMC team reporting to the Director of CMC Development Solutions (CDS).

We offer a unique opportunity to shape the content of the position and play a significant role in guiding and driving CMC development of a very broad range of international development projects and to deliver on specific CMC tasks. Our team develops tailormade CMC solutions ensuring that what we deliver to KLIFO clients is complementary to what the client can do by themselves. Our professionalism is key and your new colleagues will be highly experienced within their field of competence.

You would become part of an international and growing company with an open-minded, flexible, sharing, and trustful working climate. We have a strong focus on and interest in people and work in a respectful informal culture. We’re passionate about understanding our client’s needs and objectives and contributing to their projects as if they were our own.

You will work closely together with colleagues in other KLIFO service areas and benefit from their vast experiences within clinical operations, clinical trial supply, regulatory affairs, QA etc.

For you to thrive and be successful in this role you:

  • Enjoy contributing to many different projects
  • Manoeuvre respectfully and curiously in different company cultures and geographies
  • Are pro-active and able to take the lead
  • Have a collaborative mindset and are a flexible team player
  • Communicate confidently in writing and verbally and in Danish and English – with attention to detail

Your tasks could be to:

  • Support and advice in drug development, including documentation (protocols, reports, recommendations, presentations)
  • Develop and present CMC gap analyses, CMC strategies and plans
  • Lead CMC teams and conduct CMC project management
  • Identify CROs and CMOs and facilitate collaboration
  • Draft, review or provide input to documents for correspondence with competent authorities (briefing package/scientific advice)
  • Prepare or review documentation to support regulatory filing (module 2.3 and module 3, parts of IMPD/MMA, IND/NDA/BLA)
  • Support upscaling, validation and transfer of manufacturing processes to CMO’s
  • Outline statistical design of experiments Plan and conduct CMC due diligence incl. reporting and recommendation

Qualifications:

  • M.Sc. (pharm.) or diploma in chemical engineering or equivalent
  • +15 years drug development and CMC project management experience from pharma and/or biotech
  • Particularly strong in CMC related to phase I to phase III clinical development
  • Experience preparing regulatory documentation

Location:

KLIFO has offices in both Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark

Contact:

For more information, please contact VP Drug Development Counselling & CMC Development Solutions, Hanne Wulff Nielsen: moc.ofilk@nesleiN.ennaH +4544222903
If you want to talk to one of your future CMC colleagues and learn more about their experience working in KLIFO then we’re happy to arrange the contact.

Applications should be sent to: 

moc.ofilk@boj, marked Senior CMC Expert. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). We review applications and invite for interviews on an ongoing basis.

Deadline:

Please apply as soon as possible. Recruitment interviews will be held on an ongoing basis 

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Clinical Supply Manager

Clinical Supply Manager


KLIFO is looking for a Clinical Supply Manager for our Glostrup office

Would you like to use your solid experience within the pharmaceutical industry to join our highly skilled Clinical supply department as Clinical Supply Manager? We are growing and we need more dedicated colleagues to help us maintain and further develop our high quality level to meet client and own requirements.

The position:

As Clinical Supply Manager you will be working with a diversity of tasks from planning and coordinating clinical trials in close dialogue and cooperation with our clients. Preparation and approval of labels texts according to Annex 13, packaging materials, designs and blinding setups, coordinating return & destruction of IMP and cooperate with our distribution team in preparing distribution set ups.

You will also coordinate and collaborate with other CMO/CRO’s and ensuring a very highly quality level.

Qualifications:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs.

Also, the person must have an independent, positive, proactive and flexible personality. Our candidate is experienced with GMP and experienced within the pharmaceutical industry.

We offer:

As our new Clinical Supply Manager you will be part of an inspiring working environment in a growing company. You will work with exciting customers among competent colleagues where your knowledge, experience and contribution is valuable and highly appreciated.

  • High job variation
  • High level of influence
  • Great social working environment and commited colleagues
  • A highly flexible, free and trustful culture

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. This position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Lotte Harreby, Director at +45 44 222 969 or Pernille Smith, Team Manager at +45 44 222 986

Applications should be sent to: 

moc.ofilk@boj marked Clinical Supply Manager. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 20 December 2021 (although applications are reviewed on an ongoing basis)

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Pharmacovigilance Associate - Pharmacovigilance Solutions

Pharmacovigilance Associate


KLIFO is looking for a talented and committed Pharmacovigilance Associate based in Denmark

KLIFO is expanding our office in Denmark and wants to engage an additional Pharmacovigilance Associate into a dynamic and experienced team within Pharmacovigilance Solutions. The person we want to engage like to work in an a consulting environment and has a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position:

The Pharmacovigilance Associate is responsible for collaboration with clients and execution of projects according to the clients expectations:

  • Single Adverse Event case handling including data entry, evaluation, assessment and writing of safety narratives
  • Monitoring of the pharmacovigilance mailbox
  • Handling of safety databases
  • Preparation of pharmacovigilance and safety documents; for example Safety Management Plans, PSURs, DSURs, and safety signal reports
  • Drive medical monitoring activities
  • Maintain pharmacovigilance system master files
  • Author and review of SOPs

Qualifications:

  • MSc/BSc in the life science field, nurse or holding a diploma within Pharmacovigilance
  • Preferably > 3 years of experience from a similar position in the pharmaceutical industry/Biotech/CRO
  • Knowledge og drug safety guidelines, terminology and processes
  • Experience with safety databases
  • Excellent communication skills in English both written and verbal
  • Experienced user of MS Office and good understanding of databases
  • Able to translate client´s needs into solid deliveries

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, stablished biotech, newly started biotech and academia)
  • Build international client relations
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

KLIFO has offices in Denmark, Germany, Sweden and the Netherlands. This position is located at our office in Glostrup, Denmark

Contact:

For more information, please contact Randi Rahbæk, Senior Clinical Director  at +45 4477 8704

Applications should be sent to: moc.ofilk@boj marked Pharmacovigilance Associate

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: Please reply as soon as possible. Recruitment interviews will be held on an ongoing basis.

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QA Officer - Quality Assurance Solutions

QA Officer


KLIFO is looking for a QA Officer for our Glostrup Office

Would you like to use your QA experience as QA Officer and QP Delegate to support our highly skilled Clinical Trial Supply (CTS) department with a variety of quality tasks? And would you like to work in a client-focused company with dedicated colleagues able to support all parts of the drug and device development process? 

At KLIFO, we’re looking for a new colleague to become part of our highly experienced CTS QA Team reporting to Anders Ravn Sørensen, Team Manager, Senior QA Specialist. 

The position:

As QA Officer your work will include review and approval of master documents, receipt of goods, batch documentation review, facilitate and approve deviation and complaint handling and SOP review and writing. 

As QP delegate the tasks will include release of products packed for clinical trials. 

Qualifications:

  • Preferably you are a pharmacist or have a similar education that enables you to become a QP Delegate. 
  • The ideal candidate has minimum 3 years experience in a pharmaceutical QA or at a manufacturing/packaging site. 
  • You must be fluent in Danish as documentation and communication is in Danish.

We offer:

As our new QA Officer you will: 

  • Experience a GXP compliant quality system and production
  • Have variation in the job
  • Meet a diverse client pool (pharmaceutical companies, established biotech, inexperienced, virtual biotech, investigators/academia)
  • Get the opportunity to utilize many pharmaceutical competencies
  • Experience an interactive, open and positive working environment
  • Join a team of experienced colleagues where you use, and elaborate your skills and competencies
  • Work in an interactive, flexible and positive working environment with a high level of trust, transparency and cooperation across.

Location:

KLIFO has offices in both Denmark, Germany, Sweden and the Netherlands. This position is located at our office in Glostrup, Denmark. 

Contact:

For more information, please contact Anders Ravn Sørensen, Team Manager, +45 44 778 720 or Anne Ploug Jørgensen, Senior Director QA, +45 44 222 982. 

Applications should be sent to:

moc.ofilk@boj marked QA Officer

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: Please apply as soon as possible. Recruitment interviews will be held on an ongoing basis 

View job post as a PDF.