20 beste Stellen als regulatory specialist in deutschland – aktuell auf Personalsuche

Study Start Up Associate
Alira Health —München
- Vollzeit
- Microsoft Office
- Bachelor
Regulatory Affairs Specialist (Germany)
ProductLife Group —Home Office
- Homeoffice
- Microsoft Office
- Kommunikationsfähigkeit
Country Approval Specialist - FSP
Thermo Fisher Scientific —Home Office
- Vollzeit
- Homeoffice
- Englisch
- Bachelor
- PC-Kenntnisse
Regulatory Reporting Senior Specialist
N26 —Berlin
- Homeoffice
- Microsoft Excel
- Finanzwirtschaft
- Wirtschaft
- Umzugskostenzuschuss
- Homeoffice-Möglichkeit
Country Approval Specialist - FSP - Germany (m/f/d)
Thermo Fisher Scientific —Home Office
- Vollzeit
- Homeoffice
- Englisch
- Bachelor
- PC-Kenntnisse
3 Tage
Regional Cybersecurity Specialist M/F
Carrier —Hessen
- 81.500 € – 163.500 € pro Jahr
- Vollzeit
- Führungserfahrung
4 Tage
Medical Information Specialist - (French & English Speaking)
EVERSANA —Berlin
- Vollzeit
- Homeoffice
- Microsoft Word
- Microsoft Excel
- Schreibfähigkeiten
Direkt bewerben
4 Tage
Contract Specialist/Sr Contract Specialist - FSP Dedicated
Thermo Fisher Scientific —Home Office
- Vollzeit
- Homeoffice
- Englisch
- Forschungserfahrung
- Datenbanken
Senior Regulatory Affairs Specialist-Germany
Indero —Home Office
- Homeoffice
- Forschungserfahrung
- Bachelor
- Führungserfahrung
- Aufstiegsmöglichkeiten
- Flexible Arbeitszeiten
Direkt bewerben
Specialist Regulatory Operations (m/f/d)
Merz Therapeutics —Frankfurt am Main
- Vollzeit
Direkt bewerben
Junior Regulatory Specialist
ADM —Berlin
- Vollzeit
- Microsoft Office
Quality Asurance Specialist (m/f/d) – Clinical Supply & QP Support
Thermo Fisher Scientific —Rheinfelden
- Vollzeit
- Microsoft Office
- Bachelor
- Qualitätskontrolle
1 Tag
Regulatory Support Specialist (m/w/d), Business Unit Skin Care
URSAPHARM Arzneimittel GmbH —Saarbrücken
- Per E-Mail
- Englisch
- Microsoft Office
- Datenbanken
Referent (m/w/d) Zulassung, Regulatory Affairs Specialist
URSAPHARM Arzneimittel GmbH —Saarbrücken
- Per E-Mail
- Englisch
- Microsoft Office
- Kommunikationsfähigkeit
Global Senior Project Specialist (Sponsor Dedicated) Germany
Syneos - Clinical and Corporate - Prod —Home Office
- Vollzeit
- Homeoffice
- Englisch
- Microsoft Office
- Mit Reiseanteil
Quality Specialist Launch Team
Ball Corporation —Gelsenkirchen
- 62.300 € – 89.690 € pro Jahr
- Hybrides Arbeiten
- Schreibfähigkeiten
- Datenanalyse
- Mit Reiseanteil
- Employee Assistance Program
- Lebensversicherung
Direkt bewerben
Senior QC Specialist
Trilogy Writing and Consulting —Home Office
- Vollzeit
- Homeoffice
- Doktorat
- Microsoft Office
- Master
Direkt bewerben
Sr. Specialist - Regulatory Affairs - Operations 4C
Genpact Deutschland GmbH —München
- Vollzeit
- Englisch
- Master
- Künstliche Intelligenz
Direkt bewerben
11 Tage
AFC Specialist - Regulatory Change & Framework - Assistant Vice President (m/w/d)
Sumitomo Mitsui Banking Corporation —Düsseldorf
- 64.000 € – 96.000 € pro Jahr
- Hybrides Arbeiten
- Projektmanagement
- Finanzdienstleistungen
- Wirtschaft
10 Tage
R&D Specialist Reprocessing Intelligence (m/f/d)
Olympus Europa SE & Co. KG —Hamburg
- Doktorat
- Microsoft Office
- Master
- Kostenloser Parkplatz
- Employee Assistance Program
12 Tage

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Study Start Up Associate

Alira Health -
München

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Microsoft Office
Bachelor
Klinische Studien

Vollständige Stellenbeschreibung

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

The Study Start Up (SSU) Associate function is to support the SSU Manager with all SSU-related activities in collaboration with other clinical research stakeholders and to serve as a contact for local/global SSU process improvements.

Job Description

THE STUDY START UP ASSOCIATE ROLE

KEY RESPONSABILITIES

Coordinates and assists with all start up activities prior to site activation, including but not limited to:

Submission of required documents to ethic committees, regulatory authorities, sites and sponsor.
Submission of the clinical study agreement for review, as needed.
Contribution to/coordination of site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements.
Contribution to localize global Informed Consent Form (ICF) with country requirements.
Understanding and dissemination of information related to Ethics Committee, meeting dates & costs to relevant stakeholders.
Understanding and dissemination of information related to Ethics applications & associated online systems.
Clinical Trial Health Authority application and regulatory submission process.
Supporting with the Contracts & Indemnity request process.
Collation/provision of other materials and documentation used by the study requiring local governance approval.
Maintain up to date knowledge, ensuring study adherence and compliance with local regulatory requirements and associated documentation in line with SSU Manager oversight/input.
Contribute to collation of metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contract negotiation.
Ensure all start up information & requirements are kept up to date in a central repository for project teams.
Track metrics and study start-up timelines to identify trends and opportunities for improvement.
Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities.
Assist with identification and tracking of new sites in collaboration with CRAs.

DESIRED QUALIFICATION & EXPERIENCE

University Degree or equivalent preferably in a medical/science-related field.
Prior work experience demonstrating knowledge and understanding of clinical trials.
Demonstrated knowledge and understanding of ICH-GCP and a desire to increase specialist knowledge in regulatory, ethics and contractual requirements for SSU in clinical trials for European and international trials.

TECHNICAL COMPETENCES & SOFT SKILLS

Good communications skills including the ability to: ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.
Experience in working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
Self-motivated, assertive, and displays initiative.
Proven organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
Availability to travel domestically and internationally if required.

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.

Languages

English

Education

Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Medicine

Contract Type

Regular

Jetzt bewerben

Erweiterte Suche

regulatory specialist Jobs in deutschland

Study Start Up Associate

Regulatory Affairs Specialist (Germany)

Country Approval Specialist - FSP

Regulatory Reporting Senior Specialist

Country Approval Specialist - FSP - Germany (m/f/d)

Regional Cybersecurity Specialist M/F

Medical Information Specialist - (French & English Speaking)

Contract Specialist/Sr Contract Specialist - FSP Dedicated

Senior Regulatory Affairs Specialist-Germany

Specialist Regulatory Operations (m/f/d)

Junior Regulatory Specialist

Quality Asurance Specialist (m/f/d) – Clinical Supply & QP Support

Regulatory Support Specialist (m/w/d), Business Unit Skin Care

Referent (m/w/d) Zulassung, Regulatory Affairs Specialist

Global Senior Project Specialist (Sponsor Dedicated) Germany

Quality Specialist Launch Team

Senior QC Specialist

Sr. Specialist - Regulatory Affairs - Operations 4C

AFC Specialist - Regulatory Change & Framework - Assistant Vice President (m/w/d)

R&D Specialist Reprocessing Intelligence (m/f/d)

Ich möchte aktuelle Job-E-Mails für Stellen als regulatory specialist in deutschland erhalten

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DESIRED QUALIFICATION & EXPERIENCE

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