Novartis
Profile insights
Here’s how the job qualifications align with your profile.
Skills
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Negotiation
Education
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Bachelor’s degree
Job details
Here’s how the job details align with your profile.
Job type
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Full-time
Location
Full job description
Summary
About the Role
Major accountabilities:
The Senior Global Labelling Coordinator role is focused on three key areas of activity:
Regulatory Labelling Documentation
- You will support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions, preparing and maintaining the tracking of global regulatory dossiers for labelling projects
- Guide and support the GLM/GL-TAL, GPRD/GPRM and cross-functional experts with the review of CLP and SRP documents to ensure compliance with regulatory requirements and company standards, including formal QC.
- Independently enter and maintain current information on the labelling project in Ops RADAR including the planned global dispatch date of CLP/SRP.
- Contribute to the planning and supervision of the Phase 1 milestones for Safety Label Changes and obtain SLC Tracking Numbers from GL Compliance and Artwork Team and prepare the Reference lists for the Core Data Sheets in compliance with current documentation standards.
Independently
- Create and maintain GL functional and product-specific labelling archives
Global Labelling Committee
- Independently prepare and communicate the annual schedule of GLC and Joint GLC/MSRB meetings, scheduling the agenda, contributions and subsequent workflow as required.
- Organise the logistics of GLC and Joint GLC/MSRB meetings and distribute meeting invitations with pre-reads to the GLC (and MSRB, if applicable) members.
- Independently coordinate the timely off-line GLC review of appropriate labelling changes as agreed with the GLC Chair, compile and archive the feedback received.
- Exchange planning information and documentation directly with the members of the GLC, MSRB, GPTs as needed
Excellence and Compliance
Contribute to global labelling management and continuous improvement initiatives.
Ensure compliance of CLPs with global regulatory labelling requirements and adherence to regulatory internal policies and processes.
Provide support during HA inspections.
Act as administrator and superuser for regulatory and labelling-specific databases.
Organize and lead as subject matter expert tutorial training sessions for RA GL newcomers.
Provide administrative support to GLM, GL-TAL and Head GL as needed.
Your experience:
- Bachelors degree preferred or background in Business Administration, or experience as a Medical or Pharmaceutical Assistant.
- Fluency in English as a business language, additional languages beneficial
- Related pharmaceutical / regulatory affairs experience.
- Prior publishing/Regulatory Operations experience beneficial.
- Good communication and negotiation skills.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
To apply for this job please visit www.novartis.com.