20 beste vacatures voor de functie van safety specialist in belgium (nieuwe medewerkers gezocht)

(Sr) Country Approval Specialist - FSP - Belgium/Netherlands
Thermo Fisher Scientific —Werk van thuis
- Voltijds
- Thuiswerk
- Bachelor
- Computervaardigheden
- Medische terminologie
Quality Specialist Launch Team
Ball Corporation —Lummen
- € 62.300 - € 89.690 per jaar
- Hybride werken
- Bachelor
- Productie
- Communicatieve vaardigheden
- Levensverzekering
Snel solliciteren
Back End Specialist Launch Team
Ball Corporation —Genk
- € 502.500 - € 723.600 per jaar
- Thuiswerk
- Productie
- Communicatieve vaardigheden
Snel solliciteren
Country Approval Specialist / Sr Country Approval Specialist - FSP - Belgium
Thermo Fisher Scientific —Werk van thuis
- Voltijds
- Thuiswerk
- Bachelor
- Computervaardigheden
- Medische terminologie
Quality Specialist
Hologic —Zaventem
- € 50.000 - € 70.000 per jaar
- ERP systemen
- Microsoft Office
- Bachelor
Front End Specialist Launch Team
Ball Corporation —Genk
- € 62.300 - € 89.690 per jaar
- Thuiswerk
- Productie
- Communicatieve vaardigheden
- Levensverzekering
Snel solliciteren
Product Safety & Regulatory Compliance Specialist EU (M/V/X)
Lawter —Kallo
- Master
- Bachelor
- JavaScript
AI Quality Control Specialist - Dutch Language (NL)
e2f, inc. —Werk van thuis
- Thuiswerk
- Engels
- Artificiële intelligentie
Snel solliciteren
Product Implementation Specialist
BD —Erembodegem
- € 50.100 - € 76.425 per jaar
- Computerwetenschappen
- Engels
- ICT
Senior Specialist Customs Compliance EMEA
Ansell —Brussel
- Voltijds
- Hybride werken
- ERP systemen
- Analytisch vermogen
- Bachelor
Safety & Health Corporate Specialist
Toyota Motor Europe —Zaventem
- Microsoft Powerpoint
- Microsoft Excel
- Engels
Lab Supply Operations Specialist
Avantor —Eigenbrakel
- Voltijds
- Microsoft Excel
- Engels
- Microsoft Office
Senior Payroll Specialist
Merito —Waterloo
- Vanaf € 5.500 per maand
- Microsoft Excel
- Microsoft Office
- Financiën
- Tankkaart
Business Process Excellence Specialist Courcelles
CEVALogistics —Courcelles
- Voltijds
- Master
- Projectmanagement
- Bachelor
Field Clinical Specialist - Electrophysiology - Europe
Abbott Laboratories —Zaventem
- Voltijds
- Onderzoek
- Microsoft Office
- Organisatorische vaardigheden
Food Safety Specialist
Griffith Foods —Herentals
- € 52.600 per jaar
- Voltijds
Deco/Printer Process Specialist Launch Team
Ball Corporation —Genk
- € 62.300 - € 89.690 per jaar
- Hybride werken
- Productie
- Levensverzekering
Snel solliciteren
Safety & Health Corporate Ergo Specialist
Toyota Motor Europe —Zaventem
- Microsoft Powerpoint
- Microsoft Excel
- Engels
Sr Customer Technical Support Specialist
Ball Corporation —Genk
- € 54.000 - € 77.760 per jaar
- Hybride werken
- Engels
Snel solliciteren
Food Ingredient Formulation Scientist
HANDARY —Brussel
- Doctoraat
- Microsoft Office
- 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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safety specialist vacatures in belgium

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

Quality Specialist Launch Team

Back End Specialist Launch Team

Country Approval Specialist / Sr Country Approval Specialist - FSP - Belgium

Quality Specialist

Front End Specialist Launch Team

Product Safety & Regulatory Compliance Specialist EU (M/V/X)

AI Quality Control Specialist - Dutch Language (NL)

Product Implementation Specialist

Senior Specialist Customs Compliance EMEA

Safety & Health Corporate Specialist

Lab Supply Operations Specialist

Senior Payroll Specialist

Business Process Excellence Specialist Courcelles

Field Clinical Specialist - Electrophysiology - Europe

Food Safety Specialist

Deco/Printer Process Specialist Launch Team

Safety & Health Corporate Ergo Specialist

Sr Customer Technical Support Specialist

Food Ingredient Formulation Scientist

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van safety specialist in belgium

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