20 beste Stellen als learning development in luzern lu – aktuell auf Personalsuche

EU CTR Submission Lead
Biogen —Baar, ZG
- 100%
- Master
- Analysefähigkeit
- Bachelor
4 Tage
Global Launch and Commercial Operations Lead, Dravet
Biogen —Baar, ZG
- 100%
- Management-Erfahrung
- Doktorat
- Englisch
Room Attendant (m/w/d)
Mandarin Oriental Hotel Group —Luzern, LU
- Wochenendarbeit
- Englisch
- Master
- Reinigung
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Key Account Manager CVRM, Region West Switzerland
AstraZeneca —Baar, ZG
- Englisch
- Projektmanagement
- Kommunikationsfähigkeit
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Head of Financial Crime
AMINA Group —Zug, ZG
- 100%
- Englisch
- Master
- Analysefähigkeit
Direkt bewerben
12 Tage
Technical Presales Consultant (m/f/d) Data & AI / Automation – IBM Software (80–100%)
TD Synnex —Rotkreuz, ZG
- 100%
- Englisch
- Kommunikationsfähigkeit
Key Account Manager CVRM, Region East Switzerland
AstraZeneca —Baar, ZG
- Englisch
- Projektmanagement
- Kommunikationsfähigkeit
12 Tage
Senior Medical Director, Nephrology, Global Medical Affairs
Biogen —Baar, ZG
- 100%
- Doktorat
- Führungserfahrung
(Senior) Lead Fund Controller
Partners Group —Baar, ZG
- Microsoft Excel
- Englisch
- SQL
Portfolio Principal - Data Platform
Joyful Craftsmen AG —Zug, ZG
- 100%
- Hybrides Arbeiten
- Bachelor
- Führungserfahrung
- Kommunikationsfähigkeit
Direkt bewerben
Fullstack Developer with System Integration Focus
Asperiq —Baar, ZG
- Erfahrung mit Netzwerken
- Linux
Substitute Teacher for the Primary School
International School of Zug and Luzern —Zug, ZG
- Teilzeit
- Englisch
- Organisationstalent
- Kommunikationsfähigkeit
Direkt bewerben
Senior Director, Market Access Europe
Genmab —Zug, ZG
- Management-Erfahrung
- Englisch
- Master
2 Tage
Key Account Manager CVRM, Region Central Switzerland
AstraZeneca —Baar, ZG
- Englisch
- Projektmanagement
- Kommunikationsfähigkeit
12 Tage
Lead SAP Application Developer
V-Zug AG —Zug, ZG
- 100%
- Homeoffice
- Führungserfahrung
Global Medical Director, Evidence Generation Lead
Biogen —Baar, ZG
- 100%
- Microsoft Excel
- Doktorat
- Forschungserfahrung
5 Tage
Associate Director EU CTR Strategy & Operations Excellence Lead
Biogen —Baar, ZG
- 100%
- Management-Erfahrung
- Projektmanagement
- Führungserfahrung
Senior Counsel / Senior Investment Fund Lawyer
Partners Group —Baar, ZG
- Englisch
- Analysefähigkeit
- Personalführung
Global Relationship Manager- 3
Genpact Onsite Services - Switzerland Branch —Zug, ZG
- 100%
- Homeoffice
- Management-Erfahrung
- Englisch
- Master
Direkt bewerben
4 Tage
Global Brand & Alliance Lead
Medison Pharma —Baar, ZG
- 100%
- Microsoft Powerpoint
- Microsoft Excel
- Management-Erfahrung
Direkt bewerben

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EU CTR Submission Lead

Biogen -
Baar, ZG

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 4 Tagen

Qualifikationen

Master
Analysefähigkeit
Bachelor
Führungserfahrung

Vollständige Stellenbeschreibung

Position Summary:

The EU CTR Submission Lead is responsible for leading and overseeing the full lifecycle of regulatory submissions for clinical trials conducted under the EU Clinical Trial Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This role provides strategic submission planning, cross-functional coordination, and subject matter expertise (SME) while ensuring timely, high-quality control, and compliant submissions across the EU/EEA. The Submission Lead is a senior technical leadership role, who plays a pivotal role in mentoring junior team members without direct line management responsibilities.

Key Responsibilities

1. Regulatory Submission Leadership

Lead planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and all CTIS lifecycle activities. •
Oversee preparation and submission of Requests for Information (RFIs), ensuring high-quality and timely responses.
Provide subject matter expertise for end-of-study activities, including End-of-Trial (EoT) notifications, Summary of Results, Lay Summary, CSR and CSRr submissions.
Conduct quality oversight and ensure alignment with EU CTR, EMA guidance, and internal standards operating procedures.

2. Strategic & Cross-Functional Leadership

Serve as SME for EU CTR and CTIS processes, interpreting regulatory expectations.
Lead submission readiness activities and coordinate with internal stakeholders (Regulatory Affairs, Clinical Trial Delivery and Clinical Trial Acceleration Units, Country & site Operations and Safety).
Lead EU CTR Study Submission Team meetings to align submission strategy and timelines.

3. Compliance & Quality Oversight

Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements.
Support audits and inspections related to submission activities.
Contribute to development and maintenance of SOPs, work instructions, and templates.

4. CTIS System Expertise

Lead complex CTIS activities: dossier creation, document upload, metadata accuracy, lifecycle management, public disclosure settings.
Troubleshoot system issues and liaise with EMA as needed.
Train project teams and stakeholders on CTIS functionalities and updates.

Qualifications & Experience

Bachelor’s or Master’s in Life Sciences or related field.
5+ years’ experience with EU CTR submissions and advanced CTIS expertise.
Strong understanding of EU CTR timelines, dossier content, and results reporting.
Proven ability to lead complex submission programs.
Excellent communication, prioritization, and problem-solving skills.
Experience in pharma, biotech, or CRO.
Knowledge of regulatory intelligence and EU regulatory strategy. Core Competencies & Skills
Strategic thinking • Cross-functional leadership
Problem-solving and analytical skills
High attention to detail

Job Level: Professional

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Jetzt bewerben

Erweiterte Suche

learning development Jobs in luzern lu

EU CTR Submission Lead

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Key Account Manager CVRM, Region West Switzerland

Head of Financial Crime

Technical Presales Consultant (m/f/d) Data & AI / Automation – IBM Software (80–100%)

Key Account Manager CVRM, Region East Switzerland

Senior Medical Director, Nephrology, Global Medical Affairs

(Senior) Lead Fund Controller

Portfolio Principal - Data Platform

Fullstack Developer with System Integration Focus

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Senior Director, Market Access Europe

Key Account Manager CVRM, Region Central Switzerland

Lead SAP Application Developer

Global Medical Director, Evidence Generation Lead

Associate Director EU CTR Strategy & Operations Excellence Lead

Senior Counsel / Senior Investment Fund Lawyer

Global Relationship Manager- 3

Global Brand & Alliance Lead

Ich möchte aktuelle Job-E-Mails für Stellen als learning development in luzern lu erhalten

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