Associate Local Trial Manager
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D OperationsJob Sub Function:
Clinical Trial SupportJob Category:
ProfessionalAll Job Posting Locations:
CopenhagenJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.
Key Responsibilities
Prepare coordinate and submit EU CTR applications (initial submissions substantial modifications notifications and ASRs)
Ensure regulatory submissions are complete accurate and compliant with EU CTR and local requirements
Coordinate with internal stakeholders (Clinical Operations Regulatory Affairs StartUp teams) and external parties
Support responses to RFIs (Requests for Information) from Competent Authorities and Ethics Committees
Maintain high quality and compliance of regulatory documentation
Track submission timelines and manage multiple submissions in parallel
Required Experience
Proven experience with EU CTR submissions under Regulation (EU) No 536/2014
Experience with:
Initial CTA submissions
Substantial Modifications (Part I and/or Part II)
Notifications and lifecycle management
Experience in a pharmaceutical company CRO or clinical research environment
Required Skills:
Preferred Skills:
Analytical Reasoning Business Behavior Business English Clinical Data Management Clinical Trials Clinical Trials Operations Execution Focus Issue Escalation Laboratory Operations Process Improvements Process Oriented Project Support Regulatory Environment Research and Development Research Ethics Study Management Time ManagementRequired Experience:
Manager
Key Skills
- Restaurant Experience
- Fashion Retail
- Customer Service
- Hospitality Experience
- Store Management Experience
- Assistant Manager Experience
- Management Experience
- Retail Sales
- Leadership Experience
- Supervising Experience
- Restaurant Management
- Retail Management
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
