4 bästa jobben som regulatory specialist i jobba hemifrån (Rekryterar nu!)

Country Approval Specialist - FSP (multiple locations)
Thermo Fisher Scientific —Jobba hemifrån
- Heltid
- Distansjobb
- Engelska
- Kontor
- Kandidatexamen
6d
Site Start-up Specialist - FSP
Fortrea —Jobba hemifrån
- Heltid
- Distansjobb
- Engelska
- Microsoft Office
- Kommunikationsfärdigheter
4d
Mission Systems Technician
Metrea —Jobba hemifrån
- Heltid
- Distansjobb
- El-schema
- Engelska
- Windows
- Betald semester
- Föräldraledighet
Ansök direkt
6d
ISR Systems Technician
Metrea —Jobba hemifrån
- Heltid
- Distansjobb
- El-schema
- Engelska
- Windows
- Betald semester
- Föräldraledighet
Ansök direkt
6d

More jobs to discover

Find similar jobs that you might be interested in.

Site Start-up Specialist - FSP
Fortrea —Jobba hemifrån
Experience interacting with regulatory authorities and site start-up teams. Serve as the primary contact for investigative sites during start-up and maintenance…
4d
Country Approval Specialist - FSP (multiple locations)
Thermo Fisher Scientific —Jobba hemifrån
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and…
6d

Jag vill få den senaste jobbevakningen för regulatory specialist i jobba hemifrån

Genom att logga in på ditt konto godkänner du SimplyHireds användarvillkor och samtycker till vår cookie- och sekretesspolicy.

Utforska jobb på fler orter

regulatory specialist jobs near jobba hemifrån

Jobb som Security Engineer i Stockholms Län

Jobb som Security Engineer i Stockholm

Jobb som Security Engineer i Solna

Jobb som It Security Junior i Distans

Jobb som Embedded Software Engineer i Stockholm

Jobb som Information Security Officer i Stockholm

Jobb som Cad Engineer i Göteborg

Jobb som Locator i Stockholms Län

Country Approval Specialist - FSP (multiple locations)

Thermo Fisher Scientific -
Jobba hemifrån

Ansök nu

Jobbinformation

Heltid
6 dagar sedan

Kvalifikationer

Engelska
Kandidatexamen
Organisationsförmåga
Medicinsk terminologi
Kommunikationsfärdigheter
Förhandling

Fullständig jobbeskrivning

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

Locations: Nordics, UK, Ireland, Spain, Portugal & Italy

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).

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

Ansök nu

Förfina din sökning

regulatory specialist jobb i jobba hemifrån

Country Approval Specialist - FSP (multiple locations)

Site Start-up Specialist - FSP

Mission Systems Technician

ISR Systems Technician

More jobs to discover

Jag vill få den senaste jobbevakningen för regulatory specialist i jobba hemifrån

Utforska jobb på fler orter

Verktyg för jobbsökare

Arbetsgivarverktyg

Bläddra bland

Håll kontakten