20 Beste vacatures voor de functie van application specialist (nieuwe medewerkers gezocht)

(Sr) Country Approval Specialist - FSP - Belgium/Netherlands
Thermo Fisher Scientific —Werk van thuis
- Fulltime
- Thuiswerk
- Computervaardigheden
- Engels
- Bachelor
Application Specialist (Field Service Engineer) – Industrial Coating Systems
Nordson —Werk van thuis
- Online sollicitatie
- Thuiswerk
- Engels
- Flexibele werkuren
Junior R&I Specialist – Foundation Model
Alliander —Arnhem
- € 4.164 - € 5.948 per maand
- Fulltime
- Engels
- Analytisch vermogen
- Bachelor
- Reiskostenvergoeding
2 dagen
Application Operational Support and Deployment Specialist
SWIFT Financial Messaging Services —Leiden
- Weekendbeschikbaarheid
- Oracle
- Engels
- Databases
GC Application Specialist (Analytical Engineer)
AC Analytical Controls B.V. —Rotterdam
- Hybride werken
- Troubleshooting
- Engels
- Master
Snel solliciteren
QA Specialist
NecstGen —Leiden
- € 3.413 - € 5.409 per maand
- Fulltime
- Engels
- Master
- Analytisch vermogen
- Reiskostenvergoeding
Snel solliciteren
Specialist, QA Disposition
Bristol-Myers Squibb —Leiden
- Fulltime
- Hybride werken
- Microsoft Excel
- Engineering
- Bachelor
8 dagen
Integration Specialist
Lely —Maassluis
- € 5.015 - € 7.163 per maand
- Fulltime
- APIs
Snel solliciteren
Development Specialist
Trinseo LLC —Terneuzen
- Fulltime
- Doctor
- Engels
- Master
Specialist Calibration Technician
Bristol-Myers Squibb —Leiden
- Overwerk
- Hybride werken
- Microsoft Excel
- Engels
- Zonder diploma
Artwork & Portfolio Specialist
Tony's Chocolonely —Amsterdam
- € 55.000 - € 65.000 per jaar
- Fulltime
- Hybride werken
- Engels
- Projectmanagement
- Continue verbetering
Snel solliciteren
Ingredient Specialist
Nestlé Health Science —Almere
- Fulltime
- Microsoft Powerpoint
- Spaans
- Microsoft Excel
10 dagen
Application Support Specialist
BUNGE —Wormerveer
- Engels
- Analytisch vermogen
- Bachelor
Senior Learning & Development Specialist
Hunkemöller —Hilversum
- Fulltime
- Hybride werken
- Projectmanagement
- Klaservaring
- Productkorting werknemers
- Reiskostenvergoeding
IAM Onboarding Specialist
Alliander —Amsterdam Westpoort
- € 4.672 - € 6.675 per maand
- Fulltime
- Hybride werken
- Master
- Analytisch vermogen
- Bachelor
- Reiskostenvergoeding
2 dagen
Specialist, QA Operations Shopfloor
Bristol-Myers Squibb —Leiden
- Fulltime
- Hybride werken
- Microsoft Excel
- Computervaardigheden
- Engineering
Senior Specialist, QA Operations Shopfloor
Bristol-Myers Squibb —Leiden
- Fulltime
- Hybride werken
- Microsoft Excel
- Engineering
- Analytisch vermogen
Application Support Specialist
Intersolve —Woudenberg
- € 2.750 - € 3.750 per maand
- Fulltime
- Hybride werken
- Analytisch vermogen
- ICT
- Kosteloos parkeren
- Winstdeling
Geomatics Application Specialist
Topcon Europe Positioning B.V. —Capelle aan den IJssel
- Engels
- Kantoor
- Presentatievaardigheden
Snel solliciteren
Senior Technical Consultant, Global TFA Laboratory Capacity Strategy
Resolve To Save Lives —Werk van thuis
- Thuiswerk
- Laboratorium
- Laboratoriumervaring
- Engels

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

Thermo Fisher Scientific -
Werk van thuis

Nu solliciteren

Vacaturegegevens

Fulltime

Kwalificaties

Computervaardigheden
Engels
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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application specialist vacatures

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

Application Specialist (Field Service Engineer) – Industrial Coating Systems

Junior R&I Specialist – Foundation Model

Application Operational Support and Deployment Specialist

GC Application Specialist (Analytical Engineer)

QA Specialist

Specialist, QA Disposition

Integration Specialist

Development Specialist

Specialist Calibration Technician

Artwork & Portfolio Specialist

Ingredient Specialist

Application Support Specialist

Senior Learning & Development Specialist

IAM Onboarding Specialist

Specialist, QA Operations Shopfloor

Senior Specialist, QA Operations Shopfloor

Application Support Specialist

Geomatics Application Specialist

Senior Technical Consultant, Global TFA Laboratory Capacity Strategy

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van application specialist

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