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Choose your area of expertise

 

CLINICAL RESEARCH

 

1. Clinical Trial Assistant

The CTA is member of the clinical project team and supports the Project Manager and CRA in-house. The CTA is responsible for the administrative part of the clinical trials: correspondence, set-up documents, filing and archiving and additional tasks within the clinical project.

Requirements

  • Master Biomedical Sciences, Bachelor medical management assistant
  • Microsoft Word, Excel, Powerpoint
  • Good communication skills
  • Team spirit
  • Well organized
  • Fluently Dutch, French & English
  • Dynamic personality

 

 

2. Clinical Research Associate

The CRA is the go-between the investigator and the pharmaceutical company; ensuring that the clinical study is conducted according the guidelines. He/she is monitoring the collected data in the patients' files and the medical records, informing the investigator of incorrect or missing data.

Requirements

  • Scientific background
  • Master’s degree/ PhD in scientific area
  • Accuracy
  • Flexibility
  • Good communication & organization skills
  • Fluently Dutch, French & English

 

 

 

 

3. Clinical Data Management

The data manager handles the collected data, centralizes, verifies and validates the information in the clinical database for statistical processing. A job requiring precision, patience and stress-resistance.

Requirements

  • Scientific background
  • Master’s degree/ PhD in scientific area (Drug Development/ Biomedical Sciences)
  • Accuracy
  • Flexibility
  • Good communication & organization skills
  • Fluently Dutch & English

 

 

 

REGULATORY AFFAIRS

 

1. Regulatory Affairs Officer

The RA Officer is responsible for initiating, submitting and following up registration dossiers of new products/line extensions as well as maintaining the existing product licenses according to the current legislation. He/she keeps product leaflets and packaging material updated according to the legal requirements. He/she is responsible for the Submission of Periodic Safety Update Reports to the Health Authorities in Belgium and the creation of price and reimbursement files.

Requirements

  • Scientific degree
  • Experience in and / or full understanding of pharmaceutical regulations
  • Knowledge of Belgian and European legislation on medical products
  • Ability to engage regulators in scientific discussions
  • Excellent oral and written communication skills
  • Detail-oriented
  • Fluent in Dutch & English
  • Teamplayer
  • Pro-active, enthusiasm, keeping track of timelines

 

 

 

 

 

2. Regulatory Affairs Manager

The RA Manager is responsible for initiating, submitting and following up registration dossiers of new products/line extensions as well as maintaining the existing product licenses according to the current legislation. He/she keeps product leaflets and packaging material updated according to the legal requirements. He/she is responsible for the Submission of Periodic Safety Update Reports to the Health Authorities in Belgium and the creation of price and reimbursement files.

Requirements

  • Scientific degree
  • At least 5 years of experience in and / or full understanding of pharmaceutical regulations
  • Knowledge of Belgian and European legislation on medical products
  • Ability to engage regulators in scientific discussions
  • Excellent oral and written communication skills
  • Detail-oriented
  • Fluent in Dutch & English
  • Teamplayer
  • People Management
  • Pro-active, enthusiasm, keeping track of timelines

 

 

 

PRODUCTION

 

1. QA Release Engineer

He/she is mainly responsible for preparing and/or performing market and distribution release of medicinal products and medical devices and for providing administrative support to the QP(s) performing batch certification. He/she is also responsible for the maintenance of the applicable procedures and compliance to the current legislation, and for deviation management within his/her area of responsibility.

Requirements

  • Degree in Life Science or equivalent through experience (minimum of 5 years)
  • Basic knowledge of GMP/GDP and work experience in a quality organization
  • Excellent communication and diplomacy skills
  • Excellent administrative management skills
  • Eye for detail, accuracy and punctuality
  • Good sense of organization, planning, priority setting and initiative
  • Dutch & English

 

2. Qualified Person

The QP maintains the Company’s Manufacturing License and observes that the Company’s medicinal products are solely released in accordance with applicable legislation, relevant guidelines and requirements of local competent authorities, technical agreements. It is the overall responsibility of the QP, in collaboration with the Manufacturing License holder, to ensure that products of insufficient or dubious safety, quality and/or efficacy are not released. Any delegation of tasks to colleagues does not limit the responsibility of the QP.

Requirements

  • You obtained a Master Degree in Industrial Pharmacy and you obtained a QP number
  • You are fluent in Dutch and English
  • You value accuracy and are able carefully to read, synthesise and interpret legal texts
  • You have a strong analytical mind allowing you to focus on detail to and draw up accurate descriptions and summaries
  • You dispose of excellent communicative skills, are assertive and dynamic. Also, you like to work in a team
  • You are comfortable dealing with changing priorities and deadlines
  • You have a strong sense of initiative and organisation

 

3. Compliance Scientist

As a compliance scientist, you act as a liaison between the registration department, R&D and the plant. You oversee the compliance status of the products made on site by evaluating registration dossiers, evaluating changes to controlled manufacturing and QA systems, trending stability data (and other data) and implementing new GMP & industry regulations and regulatory requirements.

Requirements

  • Master’s degree or PhD in Biomedical Sciences, Pharmaceutical Sciences, Bioengineer, etc.
  • Strong interest in statistics and working with numbers
  • Accuracy
  • Critical and analytical mindset
  • Creative and problem solving thinking
  • Autonomous and willing to take ownership
  • Team player
  • Fluent communicator both orally and in writing
  • Excellent knowledge of English and Dutch.

 

 

4. Project Engineer

You are responsible for performing urgent quality checks, process qualification, validation and  risk assessments and preparing corresponding documentation. You implement changes, work on introduction of new products on site and you write/review protocols.

Requirements

  • Master’s degree /PhD in a scientific direction
  • A first experience in sterile drug production, project management or process validation in a GMP environment are a plus
  • Team player with strong communication skills: close collaboration with stakeholders, your team and colleagues in Production, Quality and Supply
  • Assertive, strategic, strong reasoning and analytical skills
  • You have a dynamic and enthusiastic personality and you are willing to continuously learn

 

5. Lab Technicians

You independently perform tests (raw materials, semi-finished and finished products) and report according to legal and applicable cGMP guidelines. You ensure that your knowledge of cGMP, procedures and safety is up-to-date.

Requirements

  • Bachelor’s degree in Chemistry/Pharmaceutical and Biological Laboratory Techniques or equivalent
  • Practical experience with lab analysis: non-chromatographic (analysis of raw materials, SDS, ELISA...) and/or chromatographic tests (HPLC, UPLC, GC...)
  • Strong interest in working in a GMP environment. Experience within a GMP environment is a strong asset
  • Experience with PC software applications (MS Office, LIMS) is an added value
  • Strong affinity for carrying out routine analyses
  • You can interpret and report results accurately
  • You can work both in a group and independently
  • Flexible in terms of tasks and schedule (shifts)
  • You are fluent in Dutch and English. Other languages are a plus

 

 

 

SALES & MARKETING

 

1. Brand manager

The purpose of this role is to define the Brand Strategy, develop operational and tactical plans to address the needs of all stakeholders, including enriching the patient experience in collaboration with the Brand Teams and the infield Teams and execute the marketing actions related.

Requirements

  • Experience as Brand Manager or similar functions in pharmaceutical company such as Medical, Marketing, Market access, Sales
  • Master level with a Scientific background preferred
  • Knowledge/experience in Immunology/Gastroenterology or hematology
  • Dutch, English & French

 

 

 

2. Market Access Officer/Manager

Develop the scientific backbone of the Pricing and Reimbursement dossiers based on Systematic Literature Review and/or Corporate Value Dossiers. You will write the Pricing and Reimbursement dossiers according to legislation and templates. In addition, you will monitor and analyse new governments initiatives, potential change in law and broader developments (including parliamentary activities; both regarding healthcare and industrial policies); identify key trends. You will also contribute to policy related communications efforts, including policy newsletters, position papers and advocacy documents.

Requirements

  • University degree in Sciences (preferably MD or Pharmacist) or an Economic degree with demonstrated interest in the Pharmaceutical Industry.
  • Knowledge of and experience in Market Access and/or Pharmaceutical/Regulatory Affairs is a clear asset.
  • Good understanding of the challenges of the innovative pharmaceutical sector and the healthcare sector in general
  • Experience in managing multiple tasks/projects/priorities and complex issues.
  • Proven ability to understand and clearly communicate medical and/or scientific topics
  • Fluent in French, Dutch and English

 

 

3. Product Specialist

As Product Specliast you will help launch & promote upcoming products and increase penetration to specialist in hospitals and/or private practice. You will achieve market share and volume growth by establishing privileged relations with the specialists and key decision makers of his/her product line to champion our client as a strong scientific and innovative partner within the specialty.

Requirements

  • Master’s degree/PhD in scientific area
  • Knowledge of the therapeutic would be a plus 
  • Outstanding selling skills: be able to perform excellent sales calls 
  • Experience in launching new products is an asset
  • Excellent communication skills
  • Perfect knowledge of Dutch and good command in English
  • Hard Working & Persuasive

 

 

 

MEDICAL AFFAIRS

 

1. Medical Science Liaison (MSL)

Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV).  Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area.

Requirements

  • Master’s degree/PhD in scientific area
  • Relevant expertise in medical affairs or in the relevant therapeutic area
  • Communication skills
  • Fluent in Dutch, French and English

 

 

 

2. Medical advisor

Ensuring medical and scientific information and expertise pertaining to different departments and according to the international and national standards (scientific, ethical, regulatory), in order to deliver accurate, up to date and exploitable data. Provides broad and deep understanding of the therapeutic area cross-functionally. Seen as credible medical and scientific expert by internal and external customers. 

Requirements

  • Master’s degree/PhD in scientific area
  • Relevant expertise in medical affairs or in the relevant therapeutic area
  • Communication skills
  • Fluent in Dutch, French and English

 

 

 

 

PHARMACOVIGILANCE 

 

1. Pharmacovigilance Officer (Drug Safety)

The Pharmacovigilance Officer will ensure effective and accurate collection, database entry and reporting of safety data.  He makes sure serious Adverse Events are handled according to what is described in the PV latest SOP.

Requirements

  • Scientific background
  • First relevant experience
  • Accuracy
  • Flexibility
  • Good communication & organization skills
  • Fluently Dutch, French & English

 

 

 

2. Pharmacovigilance Manager (Drug Safety)

The Pharmacovigilance Manager will ensure effective and accurate collection, database entry and reporting of safety data.  He makes sure serious Adverse Events are handled according to what is described in the PV latest SOP.

Requirements

  • Scientific background
  • At least 5 years of relevant experience
  • Accuracy
  • Flexibility
  • Good communication & organization skills
  • Fluently Dutch, French & English