Job Description:

Job information Senior Global Labelling Coordinator from the Company Novartis, this latest Senior Global Labelling Coordinator job vacancy is located in the city Hybrid work in London located in the country United Kingdom . This latest job opening is open to job seekers who have the latest education / graduate Bachelor Degree . Job Vacancies in this Senior field have been opened and published up to the specified time.

Job Responsibility:

Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The role: This role offers hybrid working, requiring 3 days per week in our White City, London office. As Senior Global Labeling Coordinator you will be responsible for providing advanced, specialized operational support to the Regulatory Affairs Global Labelling Manager, Global Labelling Therapeutic Area Lead and Head Global Labelling for the creation and maintenance of core labeling packages. These cover both development programs and marketed products. In addition, you will coordinate global labeling activities in line with regulatory requirements and company standards, to ensure timely and compliant regulatory submissions worldwide.

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

Division Development Business Unit Pharmaceuticals Location United Kingdom Site London (The Westworks) Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No

Keywords : London jobs

Closed Date : 2024-12-27