Director for Business Support

Director for Business Support


KLIFO is looking for a Director, Business Support for our Glostrup office

We are rapidly expanding our office in Denmark and we are therefore eager to fulfill a newly opened position as Director for Business Support in one of our business areas.

The new position as Director for Business Support:

Clinical Trial Supply (CTS) is a fast growing area with a great variety of ambitious projects and exciting clients. As Director you will drive the successful development of our new department Business Support.
Your main tasks will be:

  • Ensure compliance in our department, bridging to our QA and our clients.
  • Responsible for our supportive teams in CTS (Compliance, Facility Management, Qualification and process optimization) 
  • Responsible for new activities, expansions and systems
  • Process Optimisation
  • Heading and developing the Business Support Team (Currently 8 employees)
  • Financial responsible for the department and for investments

The qualifications of the Director:

  • Positive and proactive approach
  • Ability to work independently and hands on with multiple tasks under ambitious timelines
  • Experienced in GMP/GDP
  • Experienced in Qualification/validation 
  • Communication skills in Danish and English
  • Management Expirience 
  • Project Management Experience

We offer:

An exciting new position, with an opportunity to build up a strong support organization in CTS. The right candidate will have the opportunity to influence the future development of KLIFO GMP facility. Furthermore you will be part of the CTS Management team and the Extended Management team at KLIFO.

Locations:
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 Vice President Christina Vinum at +45 44 222 960. 

Applications should be sent to:

moc.ofilk@boj marked CTS Director, Business Support. 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: 15.02.2022

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Clinical Supply Assistant

Clinical Supply Assistant


KLIFO søger en Clinical Supply Assistant til klinik pakkeriet i Glostrup til hurtig tiltrædelse

Stillingen som Clinical Supply Assistant:

Som Clinical Supply Asssistent vil du få ansvar for at arbejde indenfor følgende områder:

  • Print og kontrol af etiketter
  • Udarbejdelse af etiketopsætning
  • Manuel etikettering og pakning
  • Medvirke til semiautomatiske etiketteringsprocesser
  • Forberedelse til pakning

Kvalifikationer som Clinical Supply Assistant:

  •  Erfaring med print af etiketter til klinik pakkeri
  •  Erfaring fra lignende stilling i den farmaceutiske industri
  •  GMP erfaring
  •  Stærke kompetancer i IT og teknisk minded
  •  Dansk som 1. sprog
  •  Beherske engelsk i skrift til arbejdsformål
  •  Kan lide en travl og omskiftelig hverdag
  • Ansvarsbevidst og systematisk

Vi tilbyder:

  • Et inspirerende og motiverende arbejdsmiljø i en virksomhed i vækst
  • Stor variation i jobbet
  • Indflydelse på det daglige arbejde
  • En 37 timers arbejdesuge
  • 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 Ann Ancher , Team Manager, mobil 44 22 63 51 eller moc.ofilk@rehcna.nna.

Ansøgninger skal sendes til:/span>

moc.ofilk@boj mrk. Clinical Supply Assistant.
KLIFO håndterer ansøgningen og al relateret person data specifikt for dette jobopslag. Al personlig data håndteres konfidentielt jvnf. persondataforordningen (GDPR).

Ansøgningsfrist: 30 December 2021

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Warehouse Coordinator

Warehouse Coordinator


KLIFO søger en Warehouse Coordinator til lageret i Glostrup

Stillingen som Warehouse Coordinator:

          • Varemodtagelse af produkter og materialer
          • Registrere returmedicin
          • Fremtagning af produkter til distribution
          • Forefaldende arbejde

Kvalifikationer:

          • Som Warehouse Coordinator skal du kunne trives i en travl og flexibel hverdag.
          • Gerne erfaring fra lignende stilling i den farmaceutiske industri.
          • GMP erfaring.
          • Dansk som 1. sprog.
          • Beherske engelsk i skrift og tale til arbejdsformål
          • Ansvarsbevidst og systematisk

Vi tilbyder:

          • Et inspirerende og motiverende arbejdsmiljø i en virksomhed i vækst
          • Mange forskelligartede opgaver
          • Indflydelse på det daglige arbejde
          • En 39,50 timers arbejdesuge i dagtimerne
          • 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: 22 Februar 2022

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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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eTMF Manager

eTMF Manager


KLIFO is looking for a talented and committed eTMF Manager for our Glostrup Office

KLIFO is expanding our office in Denmark and wants to engage an eTMF Manager into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have 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 as eTMF Manager:

As eTMF manager in KLIFO you will be responsible for the continuous implementation and management of Veeva Vault eTMF and associated processes. The eTMF manager is also responsible for setting up, maintaining, closing and archiving the electronic Trial Master File to ensure inspection readiness of the TMFs. The eTMF Manager is also responsible for providing comprehensive support to the clinical team for the set up and administration of projects conducted by KLIFO:

  • Participate in client’s kick-off meeting with the Clinical Team to align expectations on the TMF and related processes
  • Prepare and adapt the Trial Master File index for Sponsor and Investigator files according to the specific study
  • Create the study specific Filing Plan in alignment with the clinical team and the client
  • Create and maintain standardized templates for eTMF components and other essential documents, based on best practices and KLIFO’s procedures and in conjunction with Subject Matter Experts 
  • Plan and perform periodic TMF oversight activities to ensure Inspection Readiness at all times
  • Ensure optimal use of eTMF functionality and industry best practices by transferring manual processes into automated workflows
  • Participate in client’s recurrent meetings to provide overview and status of the eTMF 
  • Create guides for the eTMF set-up, maintenance and closure according to the TMF Milestones.
  • Create  Essential Document Lists (EDLs), dashboards, reports and metrics acc. to the system, and ensure timely TMF quality control (QC)

The qualifications of the eTMF Manager:

  • Preferably a minimum of 2 years in a similar position in the pharmaceutical industry/CRO. Candidates within Business Administration, Librarian or equivalent will also be considered
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Understanding of regulatory requirements, guidances, and industry standards that govern TMF practices
  • Experience in management and filing clinical trial documentation
  • Ability to work in cross-functional teams
  • Strong organizational, written and verbal communication skills 
  • Computer skills e.g. Microsoft Office Package
  • Previous knowledge of Veeva Vault 

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with 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 is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Jennie Wilborgsson, Clinical Research Director, at +45 93 63 88 20

Applications should be sent to: 

moc.ofilk@boj marked eTMF 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: 31 December 2021 (although applications are reviewed on an ongoing basis)

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Business Development Director

Business Development Director


KLIFO is looking for a Business Development Director for the German market in our Munich office

Would you like to become our new colleague and use your life science experience and strong network in a newly established permanent position to identify and generate leads, manage the sales process and win new business? You will report to Senior Director, New Business DACH, Christine Tiesler and work closely with the individual service areas as well as marketing and branding and business development colleagues in Germany, Denmark and Sweden.

The position:

The Director, Business Development is responsible for contributing to business growth and profitability through sales of KLIFO solutions and services to new clients in Germany. 

The primary objective of the role is to identify qualified leads, establish contact, create interest and understand clients‘ needs, manage the sales process and win new business whilst establishing and developing client relationships consistent with KLIFO Group’s culture and values.

The Director, Business Development will drive lead generation with a focus on the following KLIFO service areas; Drug Development Counselling (DDC), CMC Development Solutions (CDS), Regulatory Affairs Solutions (RAS), Quality Assurance Solution (QAS), Clinical Trial Supply Solutions (CTS), Clinical Operations Solutions (COS) and Pharmacovigilance Solutions (PVS).

You would become part of an international and growing company with a flexible and trustful working climate, healthy leadership, strong focus on and interest in people and a respectful and free culture. We believe that our way of collaborating with each other and with clients is key to our success and we have therefore described it in KLIFO’s “Way of Working” which we’re all using in our daily work.

Qualifications and Requirements:

  • M.Sc. with 10-15 years experience in the life sciences field  Minimum of 5 years experience and proven track record in converting leads to deals in a business development or sales role within life science in Europ
  • Thorough knowledge of and network within German biotech and/or biotech incubators and societies and/or German pharmaceutical companies
  • Strong commercial mindset and interest
  • Consultancy experience is desirable but not a requirement
  • PhD in life sciences is an advantage but not a requirement
  • Excellent social and client engagement skills 
  • Excellent communication and presentation skills (written and verbal)
  • Systematic and organise
  • German mother tongue; English written and spoken at professional level
  • Willingness to travel 

Your main tasks would be to:

  • Establish, maintain and own lead oversight for the German market in line with the target client profile and business plan objectives for the market
  • Pro-actively engage with potential clients to understand their needs and promote KLIFO capabilities
  • Collaborate closely with KLIFO’s service area heads, proposal managers and other key stakeholders during the sales process
  • Establish confidentiality agreements and preparing and leading client meetings and presentations
  • Support proposal development for DDC, CDS, RAS, QAS, COS, CTS and PVS and write proposals for clients for service areas without dedicated proposal managers (CDS and DDC). Liaise with client and internal stakeholders during proposal negotiation
  • Setup contractual frameworks. Negotiate contracts and work orders with clients and drive deal closures.
  • Secure hand-over to service areas after proposal acceptance
  • Suggest and implement promotional activities in collaboration with KLIFO’s communication and branding team, business development colleagues and service area heads and in line with our target client profile
  • Identify and participate in relevant industry fairs, congresses, events, networks etc, and conduct follow-up contact with prospective clients
  • Contribute to further development of KLIFO’s business development capabilities
  • Contribute to internal activities related to new business areas and internal toolbox and process improvements and business plans
  • On ad hoc basis to support new client sales in other European territories outside DACH, Benelux, Sweden and Denmark

Location:

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

Contact:

For more information, please contact: Senior Director, New Business DACH, Christine Tiesler: moc.ofilk@relseit.enitsirhc

Application:

Your application, including your CV, cover letter and expected salary range should be sent to moc.ofilk@boj marked Business Development Director Germany. 

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 are reviewing applications and invite for interviews 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 support our highly skilled manufacturing department with a variety of quality support tasks?  And would you like to work for a small and very client-focused company?

At KLIFO, we’re looking for a new colleague to become part of our highly experienced Quality Assurance Team reporting to Anne Ploug Jørgensen, Senior Director Quality Assurance.

The position:

As QA Officer you will be working with a diversity of traditional QA tasks for our local production as batch review, deviations, complaints and CAPAs as well as writing of SOPs. e

Qualifications:

Preferable you are a pharmacist or have an education that makes you able to become a QP Delegate.
You must have at least one years’ experience with QA work or pharmaceutical manufacturing.

We offer:

As our new QA Officer you will:

  • Get the opportunity to bring all your pharmaceutical competences into play in a position with many different QA tasks
  • The opportunity to develop your skills within all aspects of traditional QA and QMS
  • Later on the possibility to become a Lead auditor can be an opportunity for the right candidate
  • Join an open, flexible and positive working environment with a high degree of influence and transparency
  • Collaborate with a team of dedicated and experienced colleagues

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 Anne Ploug Jørgensen, Senior Director QA,  at +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 reply as soon as possible. Recruitment interviews will be held on an ongoing basis.

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Proposal Manager - Clinical Operations Solutions

Proposal Manager


KLIFO is looking for an experienced and skilled Proposal Manager for one of our offices in Denmark, Sweden or Germany

KLIFO is expanding our services and would like to engage a new Proposal Manager into a dynamic and experienced team within Clinical Operations Solutions.

The person we want to engage like to work in a consulting environment and have 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 as Proposal Manager:

Acts as proposal and contract leader for COS projects (DK, GER, NL and SWE). The main focus of this position is to prepare and follow-up proposal and contractual documents including budget calculation and presentation, i.e.:

  • Leader of the proposal process in COS globally
  • Receives and reviews clinical Requests for Proposals (RFPs) to ensure full understanding of the client’s requirements
  • Prepares text, budget and cover letter for to accurately reflect services to be provided, client requirements and key selling points
  • Work with COS Management, Business Development and key appointed experts to understand proposal strategy and develop proposal response and costing
  • Leads proposal development meetings
  • Use the costing model to develop budget
  • Completes client bid grids
  • Obtains third party or other KLIFO department quotes
  • Assures accuracy, consistency and competitiveness of budget, text and attachments
  • Keeps Management and Business Development informed throughout the proposal development process
  • Interacts with clients during proposal preparation, justification meetings and in bid defence
  • Prepares rebids as requested by client
  • Leader of the contract process
  • Develops, negotiates and executes client contracts in collaboration with COS Management, Business Development, Finance and Legal
  • Prepares additional contractual content and documents for example payment schedules and changes in scope

The qualifications/skills of the Proposal Manager:

  • Business Development / Outsourcing / Contracts experience from CRO, Biotech or Pharma and a minimum of 3-4 years in a similar position
  • BSc/MSc in the life sciences field or related discipline
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Action oriented and strong ability to drive things forward
  • Strong planning and task management skills
  • Organizational agility
  • Analytical skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with 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.

Contact:

For more information, please contact Vice President for COS, Klas Rådberg at +45 44 222 935

Applications should be sent to: moc.ofilk@boj marked Proposal Manager COS

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: 30 September, 2021 (although applications are reviewed on an ongoing basis)

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Medical Writer - Clinical Operations Solutions

Medical Writer


KLIFO is looking for a talented Medical Writer (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 like to work in a consulting environment and have 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 as Medical Writer (MW):

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

The qualifications of the MW:

  • 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 Clincial Study Protocols and Clinical Study Reports conforming to ICH-GCP
  • Good statistical understanding in the area of descriptive statistics
  • Ability to reproduce scientific data and complex issues accurately and in an understandable form
  • Ability to translate client’s needs into a solid project plan
  • 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 Director Jennie Wilborgsson at +45 9363 8820

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: 20 September, 2021 (although applications are reviewed on an ongoing basis)

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