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Zentiva as the champion of Generics and OTC medicines is headquartered in Prague and reaches over 40 million patients in 25 European countries. The growth of our organization brings new opportunities for our 2500 people to fulfil their potential. It also positions us well to attract best talent and retain our team to secure our success for future generations.
Regulatory Labeling Support
- Support of Labeling Specialist in preparation of Product Information (Summary of Product Characteristics -SmPC, Patient Information Leaflet -PIL, Labeling – text on packages) in line with current scientific knowledge and legislation following development of clinical findings and safety requirements and drug legislation
- Support of change control management for labeling variation, ensuring the implementation of Safety and/or Efficacy Labeling update by relevant stakeholders with quality and timely mannered processes (for updates started after relevant regulatory body outcome, further safety signal via labeling review process, or in case of update CMC variations impacting labeling)
- Regulatory and labeling databases and tools management support in order to fulfil legislation requirements and inspection readiness
- Communication and coordination of related processes with internal partners and affiliates in particular countries and regions
- Support of preparation of specific documents for EMA, linguistic phase of CP management; participation in mock-up process for harmonized and centralized part of the procedure; ensuring of User testing
- Communication with external partners while testing readability of PIL and experts while preparing clinical and nonclinical overviews in maintenance phase ( changes, renewals)
- Supporting Pharmacovigilance in terms of preparing pharmacovigilance documents
- By above mentioned activities you will participate in whole life cycle of medicinal products (development, registration, launch, continuous updating of data during maintenance)
- Scientific university background, preferably in pharmaceutical field, suitable for absolvents, students finalizing university or postgraduate study
- Experience in Labeling, Regulatory Affairs, Pharmacovigilance, or Pharmaceutical Industry would be a plus but not required.
- Sense for details and accuracy, ability to work with minimum supervision and escalate relevant information to management, capability of carrying out multiple tasks.
- Advanced spoken and written English language
- Excellent (verbal / written) communication and relational skills with all the levels of colleagues and managers internally and in extern
- Capacity of fast adaptation, flexibility, sense for information sharing as like as big precision and concentration for the control of documents
- Technical Skills with the computing tools of Microsoft word, tools of correction of documents as well as data bases. Capacity of fast learning of new necessary tools for position missions
- Great learning and experience to work with an international pharmaceutical company
- An opportunity to get and expand knowledge and skills
- Part-time job