20 Beste vacatures voor de functie van hr generalist, netherlands and belgium (nieuwe medewerkers gezocht)

(Sr) Country Approval Specialist - FSP - Belgium/Netherlands
Thermo Fisher Scientific —Werk van thuis
- Voltijds
- Thuiswerk
- Bachelor
- Computervaardigheden
- Medische terminologie
Sr CRA - FSP - Belgium & Netherlands
Thermo Fisher Scientific —Werk van thuis
- Voltijds
- Onderzoek
- Microsoft Office
- Bachelor
14 dagen
Clinical Research Associate (Belgium, Netherlands)
Allucent —Scherpenheuvel
- Hybride werken
Snel solliciteren
LINC - PhD student criminology (100%)
KU Leuven —Leuven
- Voltijds
- Doctoraat
- Schrijfvaardigheden
- Onderzoek
HR Generalist / Trajectbegeleider
De Winning —Genk
- Voltijds
- Bachelor
- Personeelszaken
- Thuiswerkopties
Data, AI and Privacy Legal Counsel – EU Hub Central
Securitas —Machelen
- Hybride werken
- Master
- Projectmanagement
- Bachelor
VIE – HR Officer Benelux
Ipsen Pharma (SAS) —Brussel
- Voltijds
- Microsoft Excel
- Engels
- Psychologie
Financial Accounting Manager Belgium, Netherlands & France
Bekaert NV —Zwevegem
- Financiën
- Master
- Accountancy
Regulatory Affairs Senior Manager Benelux
Perrigo —Gent
- Hybride werken
- Management
- Engels
- Managementervaring
8 dagen
HR Advisor - fixed term
Commonwealth War Graves Commission —Ieper
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
HR Administrator - (1-year Fixed-Term Contract with Permanent Option) - Saintes, Belgium
SportsDirect EU —Tubeke
- Voltijds
- Schrijfvaardigheden
- Microsoft Office
- Personeelszaken
Snel solliciteren
4 dagen
Junior Medical Writer
Emtex —Sint-Gillis-Waas
- Voltijds
- Thuiswerk
- Schrijfvaardigheden
- Master
- Computervaardigheden
International Recruiter Romanian & Polish Market
Werken bij STAR —Antwerpen
- Voltijds
- Engels
- Bachelor
- ICT
Snel solliciteren
Lead Animal Health Public & Government Affairs EU
Boehringer Ingelheim SComm —Brussels Hoofdstedelijk Gewest
- Voltijds
- Thuiswerk
- Engels
- Master
- Onderhandelen
HR Consultant Generalist (Senior)
Effectis —Gent
- € 3.700 - € 4.800 per maand
- Voltijds
- Hybride werken
- Bachelor
- Personeelszaken
Snel solliciteren
Assoc Director, Medical Affairs
Gilead Sciences —Brussel-Hoofdstad
- Voltijds
- Geneeskunde
- Doctoraat
- Verkoopervaring
8 dagen
Head of Market Access & Public Affairs | Belgium & Luxembourg
Boehringer Ingelheim SComm —Brussels Hoofdstedelijk Gewest
- Voltijds
- Thuiswerk
- Geneeskunde
- Verkoopervaring
- Master
International Talent Program
4PS Belgium —Gent
- Voltijds
- Doctoraat
- ERP systemen
- Master
Snel solliciteren
Legal & Regulatory Officer
Redebel —Saint-Amand
- Deeltijds
- Master
Director General & Dean HEC Liège
HEC Management School - Liège —Luik (stad)
- Doctoraat
- Onderzoek
- Master

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(Sr) Country Approval Specialist - FSP - Belgium/Netherlands

Thermo Fisher Scientific -
Werk van thuis

Nu solliciteren

Vacaturegegevens

Voltijds

Kwalificaties

Bachelor
Computervaardigheden
Medische terminologie
Communicatieve vaardigheden
Onderhandelen

Volledige vacaturetekst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:

Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPD’s target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Education and Experience Requirements:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Working Conditions and Environment:

Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves

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hr generalist, netherlands and belgium vacatures

(Sr) Country Approval Specialist - FSP - Belgium/Netherlands

Sr CRA - FSP - Belgium & Netherlands

Clinical Research Associate (Belgium, Netherlands)

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HR Generalist / Trajectbegeleider

Data, AI and Privacy Legal Counsel – EU Hub Central

VIE – HR Officer Benelux

Financial Accounting Manager Belgium, Netherlands & France

Regulatory Affairs Senior Manager Benelux

HR Advisor - fixed term

HR Administrator - (1-year Fixed-Term Contract with Permanent Option) - Saintes, Belgium

Junior Medical Writer

International Recruiter Romanian & Polish Market

Lead Animal Health Public & Government Affairs EU

HR Consultant Generalist (Senior)

Assoc Director, Medical Affairs

Head of Market Access & Public Affairs | Belgium & Luxembourg

International Talent Program

Legal & Regulatory Officer

Director General & Dean HEC Liège

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van hr generalist, netherlands and belgium

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