Regulatory Affairs Data Integrity/ Data Entry Specialist

Pracodawca:

Manpower

Opis stanowiska:

Along with ManpowerGroup Solutions, we are seeking a candidate for the position of Regulatory Affairs Data Entry/Data Integrity Specialist located in Poland to support the global processes of our client. We are offering cooperation with one of the biggest pharmaceuticals concerns in Poland. This role will work in EMEA structrue, in an international team. Competitive salary package aligned with industry standards Manpower Premium employment benefits Comprehensive healthcare coverage Sport Card to support an active lifestyle Life Insurance for additional security Training Package to support ongoing professional development Opportunity to work within a dynamic, innovative organization Clear pathways for career growth and advancement Seize this opportunity to become a vital part of a reputable organization dedicated to advancing healthcare solutions. Apply now and contribute to meaningful projects that make a difference in patients' lives. Join the team of our client and elevate your career in a stimulating and supportive environment.

Zadania:

• Update the regulatory tracking system (InSight) and/or the labeling information tracking system (LIFT) based on data entry requests received from Data Owners such as EMEA Local Operating Companies, Regulatory Management Center, and Therapeutic Area Regulatory Scientists for various regulatory procedures
• Manage data entry related to Marketing Authorization Applications, License Renewals, Labeling Variations, CMC Variations, License Withdrawals, Transfers, Expiries, and Health Authority queries
• Scrutinize data entry requests with Data Owners to ensure consistency and accuracy of data entered in systems
• Follow up with Data Owners to ensure timely completion of data entry tasks
• Maintain a comprehensive understanding of all regulatory procedures and internal documentation to ensure accurate and prompt data entry
• Collaborate effectively with Data Owners to ensure alignment and data integrity
• Support Data Owners with guidance, training, and instructions on maintaining data in InSight and LIFT systems
• Assist team members with data integrity activities, onboarding new colleagues, and acting as a Subject Matter Expert
• Provide ad hoc reports and data support for audits, inspections, and quality investigations upon request
• Coordinate data verification activities and address queries with Data Owners
• Contribute to process development and improvement initiatives within EMEA and globally
• Ensure data entry backup capabilities during team members’ vacations and holidays

Wymagania:

• Minimum of a university degree or equivalent experience in a related field
• At least 2 years of professional experience in Regulatory Affairs
• Strong understanding of Marketing Authorization data and regulatory procedures at national and EU levels
• Knowledge of regulatory data planning and tracking requirements
• Familiarity with compliance standards and advanced process thinking
• Ability to connect legal and internal company requirements with regulatory processes and task management
• Proficiency in technical skills relevant to data management systems
• Proven ability to monitor multiple actions and adhere to deadlines
• Capability to work independently and make informed decisions
• Effective in a matrix organization with cross-functional stakeholders at global, regional, and local levels
• Excellent communication skills in English, with a proactive and collaborative approach
• Adaptability to evolving regulatory environments and requirements

Oferujemy:

• Competitive salary package aligned with industry standards
• Manpower Premium employment benefits
• Comprehensive healthcare coverage
• Sport Card to support an active lifestyle
• Life Insurance for additional security
• Training Package to support ongoing professional development
• Opportunity to work within a dynamic, innovative organization
• Clear pathways for career growth and advancement

O pracodawcy:

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku funkcjonuje od 2001 roku i obecnie posiada niemal 35 oddziałów w całym kraju. Jej celem jest otwieranie przed kandydatami nowych możliwości oraz pomoc w znalezieniu pracy, która odpowiada ich kwalifikacjom i doświadczeniu.

Kontakt z firmą jest bezpłatny; można zyskać profesjonalne doradztwo oraz dostęp do ofert pracy dopasowanych do indywidualnych potrzeb.