Responsible for executing label design and reviewing related tasks in alignment with label strategy defined by the Label Lead and the established processes
Job Summary
Responsible for executing label design and reviewing related tasks in alignment with label strategy defined by the Label Lead and the established processes.
Ensures timely and accurate documentation, and status reporting to support the successful delivery of labeling activities within clinical trials.
Accountable for label compliance with respect to study design, pack design, analytical specifications of the IMP along with country specific Health Authority (HA) requirements and Novartis standards of compliance.
Matching Summary
Responsible for executing label design and reviewing related tasks in alignment with label strategy defined by the Label Lead and the established processes.
Skills & Requirements
Must-have
label design and review
timely and accurate documentation
status reporting
label compliance
country specific HA requirements
Novartis standards of compliance
Nice-to-have
participates in projects, networks and/or forums
adheres to Novartis values and behaviors
Key Requirements
> 2 years of practical experience in chemical / pharmaceutical industry
Degree in science, engineering or equivalent
Basic project management skills
Good knowledge of HSE/GMP standards and processes
Good communication, negotiation and interpersonal skills