Global Labelling Specialist

Acino Pharma

Key Responsibilities:

• Text comparison (originator, reference vs generic) and medical writing of Acino labelling-related documents (PIL, Abridged SmPCs, updates of SmPCs) as needed.
• Cross-functional collaboration with other groups (regulatory, medical affairs) for the products under own responsibility
• Prepare and and assist in maintenance of high quality Product Information (Summary of Product Characteristics - SmPC, Patient Information Leaflet - PIL, Labelling LAB (text on packaging).
• Prepare and update Company Core Data Sheet CCDS for the assigned portfolio.
• Assists in communication and coordination of related processes with affiliates (local-regional units), related departments and external partners.
• Coordinate change control process for safety/efficacy changes for dedicated portfolio.
• Assists in the organization and follow up on actions and requests pertinent to GSLC meetings, maintaining documentation, recording and tracking decisions and completion of tasks by responsible stakeholders. Lead operational meetings as applicable.

Knowledge and Skills:

• Maintains professional skills, such as labelling, clinical studies, pharmaceutical industry knowledge, communications, interpersonal skills.
• Familiar with Labelling strategic priorities, act as a Labelling specialist within the assigned company's portfolio.
• Masters knowledge in a way that it can be transferred to others. Performs Labelling operational activities, develops and maintains an effective network of relevant community.

Competencies:

Scientific & Technical & Compliance Knowledge

• Understands LAB processes and timelines.
• Completes low-risk LAB assignments.
• Active user of programs and systems.
• Aware of, understands and complies with Acino AQDs/SOPs, applicable external laws and regulations
• Acts as an internal specialist expert on labelling governance and compliance items
• Able to advise other functions, to elaborate compliant solutions under supervision

Labelling network and Strategy

• Builds internal cross-functional network.
• Actively participates in internal Labelling/PV workstreams and operational meetings
• Exchanges information in a compliant and standardized manner.
• Asks questions, tailors further information, follows-up."
• Able to deliver scientific information clearly. Able to adopt processes locally.
• Identifies and collects relevant labelling insights and shares them cross-functionally.
• Understands local situation within assigned area(s), performs LAB Inteligence and recognizes local trends.
• Understands and executes relevant LAB parts of the strategy, provides input.

Business mindset, strategic planning and thinking

• Understands company strategy and goals.
• Understands different roles in company, attends cross-functional meetings, acts reactively.
• Recognises and respects confidentiality and complies with relevant codes of conduct.
• Ensures personal compliance with relevant quality standards.
• Recognises the meaning and significance of conflict of interest.
• Preserves confidentiality of product information as appropriate.
• Seeks out diverse ideas, opinions and insights, and applies them in workplace.

Behavioral & Soft skills

• Focuses on accountability, personal learning and creating collaborative relationships
• Able to set priorities and plan own work to meet timelines. Has basic project management skills, able to execute under supervision.
• Demonstrates ethical behavior by ensuring integrity in personal and organizational practices.
• Demonstrates the importance of working together in the spirit of openness, honesty and transparency that encourages engagement and collaboration.
• Represents own interests and self-motivation.
• Learning agility and listening skills - ability to accept feedback as an opportunity to learn and improve.
• Acts in line with Arcera behaviours and values.