Lead CRA - Clinical Operations Solutions, Lund, Sweden

Lead CRA


KLIFO is looking for a talented and committed Lead CRA based in Sweden

KLIFO is expanding our office in Sweden and wants to engage a Lead CRA 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 Lead CRA:

The Lead CRA (LCRA) is responsible for the monitoring activities of trials across several sites and/or countries including proactive site management and oversight:

  • Performing feasibility and assessing suitability of clinical trial sites
  • Participate in the Risk Based Quality Management (RBQM) process with focus on the monitoring strategy
  • Development and review of Informed Consent Forms
  • Applications to Ethics Committee and review of Regulatory Submission Packages as applicable
  • Review and approval of Regulatory Green Light (RGL packages)
  • Development of study specific plans in cooperation with PM and sponsor
  • Review and approval of monitoring reports from other CRAs
  • Ensure adherence to agreed monitoring visit schedule across all sites
  • Oversight of SDV status, data entry status and data quality standards across sites. Initiate root cause analysis if not on track and escalate to PM
  • Coordinate data cleaning activities in cooperation with data management
  • Plan and lead CRA meetings to ensure knowledge sharing and common monitoring practice / implementation of study specific processes across sites
  • Training and supervision of CRAs in trial specific processes and procedures. Perform co-monitoring visits
  • Day-to-day management of central lab as applicable

The qualifications of the Lead CRA:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Experience with multi-country and multi-centre trials
  • Ability to translate client’s needs into solid deliveries
  • Ability to work independently without supervision of a colleague within the group
  • Ability to supervise and coach non-senior personnel within the group

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 both Sweden, Danmark, Germany and The Netherlands. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

Applications should be sent to: 

moc.ofilk@boj marked Lead CRA. 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:
07 February (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Regulatory Affairs Officer, Munich, Germany

New established position as Regulatory Affairs Officer


New established position as Regulatory Affairs Officer

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

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Senior Director New Business DACH in Munich.

The position as Regulatory Affairs Officer may involve:

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): Briefing packages, IMPD, IND, MAA/NDA, Variations, Renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

  • M.Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Fluent in German and English
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organizational skills with attention to details
  • Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player and possesses excellent planning 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)
  • Join a team of experienced colleagues where you use and elaborate your skills and competences
  • Work in an interactive, flexible and positive working environment with a high level of transparency
  • Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. This position is located at our office at Heimeranstrasse 35 in Munich.

Contact:

For more information, please contact Senior Director Christine Tiesler at +49 89 895286-31

Applications including salary expectations should be sent to: moc.ofilk@boj marked “Regulatory Affairs Officer, Munich”.

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).

View job post as a PDF.


QA Officer, GMP

QA Officer, GMP

 


KLIFO is looking for a QA Officer, GMP for our Glostrup Office

The position as QA Officer, GMP
We are a growing QA department and one of our main responsibilities is quality assurance of KLIFO´s Clinical Trial Supply.

The work will include review and approval of master documents, receipt of goods, batch documentation review, facilitate and approve deviation and complaint handling and release of products for clinical trials as QP delegate.

The qualifications of the QA Officer, GMP:

  • You must have an MSc in a life science area that makes you qualified to be QP Delegate (Pharmacist, Engineer or similar).
  • The ideal candidate has minimum 3 years experience in a pharmaceutical manufacturing/packaging site.
  • You must be fluent in Danish as documentation and communication is in Danish.

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 competencies
  • 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 transparency

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, mobile phone +45 44 222 982.

Applications should be sent to: moc.ofilk@boj marked QA Officer, GMP.
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.

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. For more information, visit www.klifo.com


Experienced Clinical Research Associate

Experienced Clinical Research Associate Clinical Trials in Germany


Experienced Clinical Research Associate Clinical Trials in Germany

KLIFO  wants to appoint an experienced Clinical Research   Associate   into  a  dynamic   and  experienced team  within Clinical  Operations  Solutions  in  Germany. 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 Clinical Research Associate (CRA):

The CRA has considerable knowledge and is responsible as primary contact for investigational sites, conduct of monitoring activities and for assistance of the Project Manager:

  • Continuous relationship with the Principal Investigators and trial staff to assure the success of the trial in terms of enrolment and quality
  • Visiting investigator and investigational site before a specific trial: pre-trial/site assessment visits
  • Performing initiation, routine monitoring and close-out visits
  • Elaboration of trial specific procedures
  • Participation in the preparation of trial documents for submissions to Competent Authorities and Ethics Committees/Institutional Review Boards
  • Support to data management activities
  • Assist in ensuring site compliance with protocol and trial objectives
  • Work in the clinical trial team, reporting to project manager for trial related deliverables
  • Translation/review of essential documents
  • Liaison between sponsors, investigators and vendors
  • Project management

Qualifications:

  • Minimum 2 years of experience as CRA within industry/CRO/BioTech
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent verbal and communication skills
  • Native speaker of German of comparable level (e.g. able to translate patient documents or ICFs into German, able to talk and email in German with site personnel)
  • B.Sc. in the life sciences field or CRA specific diploma
  • Good computer skills, ability to develop and maintain excel spreadsheets, handling of access database and to elaborate PowerPoint presentations.
  • Strong organizational and planning skills
  • Accurate and precise with attention to details
  • Ability to motivate

In addition the ideal candidate is a dedicated and collaborative team player, and fluent, spoken and written, in English.

In addition the ideal candidate is a dedicated and collaborative team player and fluent, spoken and written, in English

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:

This position is located at our office in Munich.

Contact:

For more information, please contact Dr. Michaele Kupka, Team Manager CRAs & Project Manager at +49 89 895286-0

Applications should be sent tojob@klifo.com marked “CRA, Munich”.

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).

View job post as a PDF.


Lead CRA (LCRA) - Clinical Operations Solutions, Glostrup, Denmark

Lead CRA


KLIFO is looking for a talented and committed Lead CRA (LCRA) based in Denmark

KLIFO is expanding our office in Denmark and wants to engage a Lead CRA 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 Lead CRA:

The Lead CRA (LCRA) is responsible for monitoring activities of trials across several sites and/or countries including pro-active site management and oversight:

  • Performing feasibility and assessing suitability of clinical trial sites
  • Participate in the Risk Based Quality Management (RBQM) process with focus on the monitoring strategy
  • Development and review of Informed Consent Forms
  • Applications to Ethics Committee and review of Regulatory Submission Packages as applicable
  • Review and approval of Regulatory Green Light (RGL packages)
  • Development of study specific plans in cooperation with PM and sponsor
  • Review and approval of monitoring reports from other CRAs
  • Ensure adherence to agreed monitoring visit schedule across all sites
  • Oversight of SDV status, data entry status and data quality standards across sites. Initiate root cause analysis if not on track and escalate to PM
  • Coordinate data cleaning activities in cooperation with data management
  • Plan and lead CRA meetings to ensure knowledge sharing and common monitoring practice / implementation of study specific processes across sites
  • Training and supervision of CRAs in trial specific processes and procedures. Perform co-monitoring visits
  • Day-to-day management of central lab as applicable

The qualifications of the Lead CRA:

  • BSc. in the life sciences field or related discipline and a minimum of 3-4- years in a similar position in the pharmaceutical industry/Biotech/CRO
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Experience with multi-country and multi-centre trials
  • Ability to translate client’s needs into solid deliveries
  • Ability to work independently without supervision of a colleague within the group
  • Ability to supervise and coach non-senior personnel within the group

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 will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Stine Larsen, Director, KLIFO A/S at +45 4422 2959

Applications should be sent to: 

moc.ofilk@boj marked Lead CRA. 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:
23 November 2020 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Manager


KLIFO is looking for a talented and committed Project Manager (PM) based in Denmark

KLIFO is expanding our office in Sweden and wants to engage Project Managers 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 Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial. 
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Experience within clinical trial management, preferably within phase 1
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • 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 in English)
  • Microsoft Office 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 Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Jennie Wilborgsson, Clinical Research Director, KLIFO A/S at +45 9363 8820

Applications should be sent to: 

moc.ofilk@boj marked Project 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:
23 November 2020 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Regulatory Affairs Officer, Munich, Germany

New established position as Regulatory Affairs Officer


New established position as Regulatory Affairs Officer

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

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Senior Director New Business DACH in Munich with a dotted line to our VP Regulatory Affairs in Denmark.

The position as Regulatory Affairs Officer may involve:

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): Briefing packages, IMPD, IND, MAA/NDA, Variations, Renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

  • Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organizational skills with attention to details
  • Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player, possesses excellent planning skills and is fluent, spoken and written, in English and Danish.

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 an interactive, flexible and positive working environment with a high level of transparency
  • Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Location:

KLIFO has offices in Denmark, Germany and Sweden. This position is located at our office at Heimeranstrasse 35 in Munich.

Contact:

For more information, please contact Senior Director Christine Tiesler at +49 89 895286-31

Applications including salary expectations should be sent to: moc.ofilk@boj marked “Regulatory Affairs Officer, Munich”.

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).

View job post as a PDF.


Director - Data Management and Biostatistics, Munich, Germany

New established position as Regulatory Affairs Officer


New established position as Regulatory Affairs Officer

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

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Senior Director New Business DACH in Munich with a dotted line to our VP Regulatory Affairs in Denmark.

The position as Regulatory Affairs Officer may involve:

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): Briefing packages, IMPD, IND, MAA/NDA, Variations, Renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

  • Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organizational skills with attention to details
  • Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player, possesses excellent planning skills and is fluent, spoken and written, in English and Danish.

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 an interactive, flexible and positive working environment with a high level of transparency
  • Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Location:

KLIFO has offices in Denmark, Germany and Sweden. This position is located at our office at Heimeranstrasse 35 in Munich.

Contact:

For more information, please contact Senior Director Christine Tiesler at +49 89 895286-31

Applications including salary expectations should be sent to: moc.ofilk@boj marked “Regulatory Affairs Officer, Munich”.

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).

View job post as a PDF.


Project Manager - Clinical Operations Solutions, Lund, Sweden

Project Manager


KLIFO is looking for a talented and committed Project Manager based in Sweden

KLIFO is expanding our office in Sweden and wants to engage Project Managers 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 Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial. 
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Experience within clinical trial management, preferably within phase 1
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • 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 in English)
  • Microsoft Office 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 both Denmark, Germany and Sweden. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

Applications should be sent to: 

moc.ofilk@boj marked Project 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:
08 November 2020 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Medical Writers - Clinical Operations Solutions, Lund, Sweden

Medical Writers


KLIFO is looking for talented and committed Medical Writers based in Sweden

KLIFO is expanding our office in Sweden and wants to engage Medical Writers into a dynamic and experienced team within Clinical Operations Solutions. The areas covered by KLIFO also include Clinical Trial Supply Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

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 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

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 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
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • 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

In addition to the above-mentioned qualifications the ideal candidate is a service minded and collaborative team player that possesses planning skills, attention to detail and is fluent, spoken and written, in English and in a Scandinavian language.

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.

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

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

Deadline: 

08 November 2020 (although applications are reviewed on an ongoing basis)

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

View job post as a PDF.