Senior Regulatory Affairs Specialist, DE

Senior Regulatory Affairs Specialist, Munich, Germany


KLIFO is looking for an enthusiastic and self-motivated individual to develop our regulatory affairs team in Munich, Germany

The position

KLIFO is an integrated drug development consultancy with headquarters in Denmark. In early 2019, KLIFO acquired medicomp GmbH, a Munich-based company providing life science services to pharmaceutical, medical device and biotech companies. The acquisition of medicomp is part of KLIFO’s strategy to expand the company’s operational footprint. 

KLIFO is currently expanding its service offering in Germany by introducing an end-to-end drug development consultancy, similar to what the company has in Denmark, including a Regulatory Affairs Solutions department. 

The Senior Regulatory Affairs Specialist will be responsible for building up and leading a Munich-based regulatory affairs team and supporting the establishment of new regulatory affairs business in Germany and the DACH region. In addition, the position requires a hands-on approach to service existing and new clients. The successful candidate will report to the Head of New Business in Munich and work in close collaboration with the Vice President, Regulatory Affairs Solutions from company headquarters in Denmark.

Functions as Regulatory Affairs team Leader 

  • Identify and recruit candidates with solid regulatory affairs experience, in close collaboration with the HQ regulatory affairs team
  • Provide leadership for the Munich-based regulatory affairs team as it grows
  • Client liaison, project execution and oversight to ensure client satisfaction
  • Develop the regulatory affairs business with current and potential DACH-based clients
  • Promote KLIFO and its integrated drug development solutions offering by participating in conferences and other networking events etc

Functions as Senior Regulatory Affairs Affairs Specialist

  • Project management
  • Strategic advice
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of regulatory documents, e.g. (non-exhaustive list):
  • Briefing packages
  • IMPD
  • CTA/IND 
  • ODD
  • PIP
  • MAA/BLA/NDA
  • Project management and cross-functional collaboration within KLIFO
  • Support to projects in other KLIFO departments
  • Writing and reviewing of SOPs

Qualifications and requirements

  • MSc from the life sciences field or Regulatory Affairs specific diploma/master and a minimum of 15 years’ experience within Regulatory Affairs 
  • Profound knowledge of regulatory guidelines, terminology and processes
  • Experience in liaison with Medicines agencies especially PEI and BfArM
  • Broad knowledge of the key drug development steps
  • Proven track record with good leadership skills
  • Collaborative mind-set
  • Personal fit with KLIFO’s culture and way of working
  • Extrovert service oriented (client-centric) mindset, preferably with experience from pharma and biotech as well as service provider side
  • Able to work internationally
  • Passion for developing the KLIFO regulatory affairs business provided out of the Munich office
  • Network of regulatory experts in DACH
  • Excellent communication skills, fluent in German and English (both written and verbal)
  • Experienced user of MS Office and good understanding of databases
  • Strong organisational skills with attention to details
  • Willingness to work from client sites, when required
  • Ability to travel for work (in Europe, up to 25%)

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) 
  • Join a team of experienced colleagues where you use and elaborate your skills and competences 
  • Work in a European-based company with global reach 
  • Work in an interactive, flexible and positive working environment with a high-level of transparency and influence
  • Flexibility to work partially home-based

The position is located at KLIFO GmbH, Heimeranstr. 35, Munich Germany

Applications

Applications, including salary expectations, should be sent to Christine Tiesler, Head of New Business, KLIFO GmbH at moc.ofilk@relseit.enitsirhc.

View job post as a PDF.

For more information about KLIFO, visit www.klifo.com.


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Project Manager DE

Project Manager


KLIFO is looking for a talented and committed Project Manager, Clinical Trials, Germany

KLIFO A/S is expanding and just established its first subsidiary outside Denmark in Munich, Germany. KLIFO GmbH now wants to appoint a Project Manager

for the conduct of clinical trials into a dynamic and experienced team within Clinical Operations Solutions in its Munich office. 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.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as Project Manager (PM):

The Project Manager is overall responsible for managing the clinical trials, i.e.:

  • Management of assigned trials in all phases, from start-up to the end of the project, both as overall project manager in close collaboration with the sponsor and as local project manager faithfully managing the local study responsibilities in the context of a larger study setting
  • Leadership of people involved in the project (CRAs, CTA, etc.)
  • Training and supervision of external staff and subcontractors
  • Investigational site selection in order to assure the quality and conformity of the sites
  • Coordinating cross-functional project teams in relation to trial(s)
  • Operational and scientific input to key project documents
  • Continuous relationship with the Principal Investigators and Sponsor to assure the success of the trial in terms of enrolment and quality
  • Management and resolution of issues occurring during the trial
  • Generation and management of Project Plans
  • Coordination and Implementation of Risk Management Activities
  • Training of Investigators and Monitors and organization and conduct of appropriate meetings
  • Elaboration of trial specific procedures
  • Monitoring of selected sites, e.g. KoL

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications and skills:

  • MSc in the life sciences field or a medical/veterinary degree and at least 5-6 years overall experience out of which 2 years in project management in thepharmaceutical industry/BioTech/CRO
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Demonstrated project management skills including the ability to plan and conduct an international, multicountry clinical trial and operate within plan andbudget
  • Willingness to travel
  • Excellent verbal and written communication skills
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations.
  • Fluent in English and in German (spoken and written)

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.

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

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO can be found at www.klifo.com

Applications, including salary expectations, should be sent to:

moc.ofilk@boj

View job post as a PDF.


Biometrician/Biostatistician

Biometrician/Biostatistician


KLIFO is looking for a talented and committed Biometrician/Biostatistician

KLIFO A/S is expanding and is expanding and has just established its first subsidiary outside of Denmark – in Munich, Germany. KLIFO GmbH is looking to appoint a Biometrician/Biostatistician for the planning, analysis and reporting of clinical trials. The successful candidate will be part of a dynamic and experienced team within Clinical Operations Solutions and will work from our offices in either Munich or near Copenhagen, Denmark. The people we want to engage have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible and trust-based working environment with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as Biometrician/Biostatistician within Clinical Operations Solutions:

Responsibilities of the Biometrician/Biostatistician include:

  • Act as the primary contact person for our customers concerning trial-related statistical aspects
  • Provide statistical consultancy on general or trial‑related aspects, internally and externally
  • Cooperate closely with data managers, SAS®programmers and project managers
  • Coordinate small teams of SAS®programmers, perform quality control of SAS®programs
  • Statistical planning of clinical trials: provide statistical input to trial designs and perform sample size calculations
  • Writing or peer review of the statistical sections of clinical trial protocols
  • Writing or peer review of statistical analysis plans
  • Perform statistical analyses using SAS®
  • Provide statistical contributions to clinical trial reports
  • Provide statistical support for publications
  • Support maintenance and further development of internal standards and of Standard Operating Procedures.

The qualifications of the Biometrician/Biostatistician:

The Biometrician/Biostatistician should possess the following qualifications and skills:

  • Diploma or master in (bio-)statistics, mathematics or comparable degree
  • Professional experience with planning, analysis and reporting of clinical trials in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Knowledge of relevant regulatory guidelines
  • Profound knowledge of SAS®and Microsoft®Office
  • Familiarity with CDISC standards
  • Quality orientation, efficiency, and reliability
  • Customer orientation and flexibility
  • Willingness to travel occasionally
  • Excellent verbal and written communication skills
  • Fluent in English (spoken and written), and in either German or Danish.

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.

We offer:

  • Work within different therapeutic areas and with tasks of varyingcomplexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech,investigators/academia)
  • Use – and elaborate – your competences and experience
  • A team of experienced colleagues
  • Work in a European-based company with global reach
  • Work in an interactive, flexible and positive working environment.

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO can be found at www.klifo.com

Applications, including salary expectations, should be sent to:

moc.ofilk@boj marked “Biometrician/Biostatistician”

View job post as a PDF.


Data Manager/Programmer Clinical Trials

Data Manager/Programmer Clinical Trials


KLIFO is looking for a talented and committed Data Manager/Programmer

KLIFO A/S is expanding and has just established its first subsidiary outside of Denmark – in Munich, Germany. KLIFO GmbH is looking to appoint a Data Manager/ Programmer for clinical trials. The successful candidate will be part of a dynamic and experienced team within Clinical Operations Solutions and will work from our offices in either Munich or near Copenhagen, Denmark. The people we want to engage have a positive, proactive, flexible, self-driven and self‑confident personality. We can offer a highly flexible and trust-based working environment with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as Data Manager/Programmer within Clinical Operations Solutions:

Responsibilities of the Data Manager/Programmer include:

  • Cooperate closely with biostatisticians, medical reviewers and project managers
  • Database set-up and testing, usually within an eCRF system
  • Set-up and testing of online edit checks
  • Program (within the eCRF system or in SAS®) various listings, overviews and summary tables for medical reviewer, status reports, project management; provide updated outputs on a regular basis
  • Support programming (in SAS®) of data listings for clinical study reports
  • Perform quality control of programs
  • Writing or peer review of Data Management Plans and Data Validation Plans
  • Continuous data cleaning, data base lock
  • Support maintenance and further development of internal standards and of Standard Operating Procedures
  • Contribute to harmonization of data management processes between KLIFO offices.

The qualifications of the Data Manager/Programmer:

The Data Manager/Programmer should possess the following qualifications and skills:

  • Professional data management experience in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Experience with the use of eCRF systems to set up eCRFs and online checks and to perform continuous data management activities
  • Very good SAS®programming skills are important
  • Familiarity with CDISC standards
  • Knowledge of relevant regulatory guidelines
  • Analytical thinking, familiarity with medical terminology
  • Quality orientation, efficiency, and reliability
  • Customer orientation and flexibility
  • Willingness to travel occasionally
  • Fluent in English (spoken and written), and in either German or Danish.

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.

We offer:

  • Work within different therapeutic areas and with tasks of varyingcomplexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech,investigators/academia)
  • Use – and elaborate – your competences and experience
  • A team of experienced colleagues
  • Work in a European-based company with global reach
  • Work in an interactive, flexible and positive working environment.

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO can be found at www.klifo.com

Applications, including salary expectations, should be sent to:

moc.ofilk@boj, marked “Data Manager/Programmer

View job post as a PDF.


Compliance Coordinator, QA

Compliance Coordinator, QA


KLIFO is a leading drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development project. KLIFO provides consultancy and operational solutions within all areas of clinical research, clinical trial supply, regulatory affairs, pharmacovigilance, CMC Development, QA and development of pharmaceutical and biotech products and medical devices
We want to engage a person with a positive, proactive, flexible and self-confident personality, who would like to work in a consulting environment.

The Compliance Coordinator, QA will be responsible for:

  • Administration, Quality oversight and management of KLIFO’s QA Management System
  • Responsible for maintaining an archiving system
  • SOP updates and writing of new SOPs within the quality area
  • Approval of quality related documents from GMP areas as SOPs, Deviations, Complaints and CAPAs
  • For the right person there will be opportunity in this position to become a Delegate Qualified Person and to be trained and qualified as GMP auditor

The Compliance coordinator, QA must have a academic background and some experience from working with medicinal products. You must be service minded and fond of systems and organization. You must be used to communicating in English

We offer:

  • GXP compliant quality system and production
  • Variation in the job
  • Diverse client pool (pharmaceutical companies, established biotech, inexperienced, virtual biotech,
    investigators/academia)
  • Opportunity to utilize many pharmaceutical competences
  • An interactive, open and positive working environment
  • High level of transparency – and influence
  • Room for individual planning

The position is new and there will be possibilities influence the job content so it will fit the experience of the selected person.

For information about the position you can contact Director, QA – Anne Ploug Jørgensen +45 44 222 982

 

Application:

Applications for the job must be send to; moc.ofilk@boj

 

Deadline:

February 18, 2019.


Qualification Coordinator

Qualification Coordinator


KLIFO is a leading drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development project. KLIFO provides consultancy and operational solutions within all areas of clinical research, clinical trial supply, regulatory affairs, pharmacovigilance, CMC Development, QA and development of pharmaceutical and biotech products and medical devices

We want to engage a person with a positive, proactive, flexible and self-confident personality, who would like to work in a consulting environment.

The Qualification Coordinator will be responsible for:

  • Planning and executing qualifications, including re-qualification of in-house facilities and equipment
  • Handling of Change Requests and deviations
  • Writing protocols and test plans for qualification
  • Perform qualification activities
  • Gather test results and documentation and write qualification reports
  • Responsible for equipment (service/maintenance)
  • Participate in Self inspections and audits (when required)
  • Participate in planning of new equipment and expansion/changes of equipment and facilities

The Qualification coordinator must have experience and interest for working with qualification, including related documentation and from working with medicinal products. You must be service minded and flexible.

You must be used to communicating in English.

We offer:

  • GXP compliant quality system and production
  • Variation in the job
  • Opportunity to utilize many pharmaceutical competences
  • An interactive, open and positive working environment
  • High level of transparency – and influence
  • Room for individual planning

The position is new and there will be possibilities influence the job content so it will fit the experience of the selected person.

 

Location:

KLIFO is located at Smedeland 36, 2600 Glostrup.

 

Contact:

For more information about the position you can contact Director – Henriette Pedersen +45 44 222 962

 

Application:

Applications for the job must be send to; moc.ofilk@boj

 

Deadline:

February 18, 2019.


Director for Clinical Trial Supply Distribution

Director for Clinical Trial Supply Distribution


KLIFO is a leading drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development project. KLIFO provides consultancy and operational solutions within all areas of clinical research, clinical trial supply, regulatory affairs, pharmacovigilance, CMC Development, QA and development of pharmaceutical and biotech products and medical devices

We want to engage a person with a positive, proactive, flexible, service minded and self-confident personality, who would like to work in a consulting environment.

Clinical Trial Supply Distribution consists of 7 experienced Logistic Coordinators that handle all distribution within KLIFO in close cooperation with our production Operators.

The Director will be in reference to Vice President, Clinical Trial Supply.

 

The Director will be responsible for:

  • Daily Management of the Distribution department
  • Participating in the operational work
  • Close cooperation with the other Directors in Clinical Trial Supply
  • Maintain relations with our clients, through dialog and close cooperation
  • Close contact with our Subcontractors for courier services
  • Responsible for establishing new depots and maintain contracts
  • Establish a strategy for distribution in cooperation with the distribution team
  • Monthly reporting of executed and planned shipments on project level
  • Respond to distribution related customer enquiries in cooperation with Project Managers
  • Approval of invoices from Subcontractors
  • Be the expert on incoterms
  • Participate in audits of subcontractors (specialist level)
  • Participate in Self inspections and audits (when required)
  • Participate in Budget planning and Business plan development together with Supply Management team (Directors and Vice President)
  • Participate in KLIFO Extended Management Team

The ideal Candidate has experience within distribution and Management. A broad knowledge within GDP and knowledge in GMP and GCP is required.

IT knowledge at user level is required and you must be used to communicating in English

 

We offer:

  • A challenging job in a well-functioning team
  • An interactive, open and positive working environment
  • High level of transparency – and influence
  • Room for individual planning

The position is new and there will be possibilities to influence the job content so it will fit the experience of the selected person

 

Location:

KLIFO is located at Smedeland 36, 2600 Glostrup.

 

Contact:

For more information about the position you can contact Vice President Christina Vinum, +45 44 222 960

 

Application:

Applications for the job must be send to; moc.ofilk@boj

 

Deadline:

February 18, 2019.


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