Łukasz Tobiasz

• providing very high quality labeling/product information for new registrations and assigned post-approval variations (Summary of Product Characteristics/SmPC, Patient Leaflet/PIL, packaging texts) in order to maintain the products on the market [continuous co-operation with: Senior Regulatory Affairs Manager (SRAM), Senior Regulatory Professional (SRAP), EMEA RA Labelling Operations, Global Labeling Centre of Excellence, external agencies (i.e. translators, companies preparing patient readability report, etc)];
• organizing the process of the reviewing product information in accordance with the EU/local terms, provisions, templates (QRD) and assuring appropriate communication in a team (involved in the verification process);
• providing monthly analysis of labeling activities;
• updating labeling (SmPC, PIL, packaging) in the database (intranet, www.janssen.pl) in order to implement the strategy of sale, HEMAR, distribution and medical departments;
• working with quality and logistic departments to ensure continuity of supply providing relevant data relating to the processes of post-marketing.
• responsibility for the results of the audits in the Regulatory Affairs/RA area (Labeling Internal Audit- 2014; Records Management Internal Audit- 2016)- “no critical”, “no major” observations.
• archiving of documents in the RA area in accordance with company procedures (cooperation with the company Iron Mountain).
• responsibility for updating the Records Retention Schedule (RRS)/plan od storing documents, in accordance with the Johnson & Johnson policies.
• back-up of PACKMAT Coordinator.

• participating in the preparation of the first edition of an Official list of veterinary medicinal products.
• introducing the Official list of veterinary medicinal products.
• preparation and edition of responses to official letters from: pharmaceutical companies, state institutions and individuals.
• updating on-line Official list of medicinal products for post-marketing changes (CITS system).
• dealing with circulation of documents between the relevant departments of Division of Medicinal Products.
• recording documentation.

Sales of telecommunications services.

Sales of telecommunications services.