Manager/Sr. Manager, Global Labeling Operations

☞ Incyte

View: 135

Update day: 24-04-2024

Location: Morges Vaud VD

Category: Other

Industry: Biotechnology Research Hospitals Health Care Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

Loading ...

Job content

Summary

The Manager/Senior Manager, Labelling Operations will be responsible for regulatory support (both technical and operational) in the area of product labelling for Incyte’s marketed products. This position reports to the Director, Global Labeling Regulatory Affairs and will be responsible for the creation and maintenance of packaging mock-ups and artwork throughout the product lifecycle. This position will manage translations of labelling content and support the Regulatory Liaisons with drafting and revising regional/local product information documents.

Duties And Responsibilities
  • Leads and manages the development of new and updated packaging mock-ups and artwork for submission purposes and coordinates their review with members of the Commercial, Supply Chain, Quality, and Regulatory Affairs (including Incyte local subsidiaries, contractors, and partners) organizations.
  • Oversees the review and approval of local packaging artwork by local Regulatory Affairs (including Incyte subsidiaries, contractors, and partners).
  • Liaises with local Regulatory Affairs (including Incyte subsidiaries, contractors, and partners) to collect local Health Authorities’ requirements for specific labelling-related topics (e.g. bluebox content, braille, pictograms, product codes, reimbursement information, serialization and other anti-counterfeiting measures).
  • Participates on the Global Packaging Committee providing product information updates and timelines.
  • Manages the linguistic review and translations of labelling content.
  • Performs quality checks of labelling documents ensuring document complies with the appropriate template (e.g., QRD) and packaging mock-ups and artwork to ensure adherence to regulatory requirements and formatting guidelines.
  • Manages product information on local databases/compendia.
  • Supports Regulatory Liaisons with activities related to package leaflet readability testing and tracking of deviations to the Company Core Data Sheet (CCDS).
  • Support Regulatory Liaisons in the initial creation and relevant updates to regional/local product information documents, primarily focusing on EU Summary of Product Characteristics (SPC), UK SPC, Swiss prescribing information and their associated patient labelling documents.
Requirements
  • Bachelors degree in a scientific discipline or equivalent required.
  • 3-5 years of pharmaceutical experience or relevant professional experience.
  • Experience in labelling and artwork processes and knowledge of regulatory systems.
  • Experience working with vendors for translation services and/or local affiliates preferred.
  • Experience in drug development and knowledge of global regulatory submission content and formats.
  • Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines.
  • Excellent organization, communication, and writing skills.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here .

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Loading ...
Loading ...

Deadline: 08-06-2024

Click to apply for free candidate

Apply

Report job
Loading ...
Loading ...

SIMILAR JOBS

Loading ...
Loading ...