METAP Labelling Specialist at Abbott

Algiers, Algiers, Algeria

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

Knowledge of internal processes and local/international regulatory requirements for labelling
Ability to coordinate with affiliates, internal departments, external partners (e.g., Third Party Manufacturers), Supply Chain, Quality, regulatory, Medical, and marketing teams
Proficiency in using validated tools and systems for label change workflow, including proofreading
Skills in managing local language translations of PIL/labels
Capability to track, follow-up, and communicate implementation status
Experience in maintaining archives, databases, and record retention for approved labelling materials
Ability to create and maintain local procedures and documents
Expertise in identifying and resolving labelling issues (e.g., errors, inconsistencies between package leaflet and SmPC)
Support for Pharmacovigilance, local/regional audits preparation and execution
Understanding of MEAP local regulatory requirements to advise business partners

Responsibilities

Support managing labelling activities in METAP coverage areas for timely completion per internal processes and regulatory requirements
Coordinate submission planning, preparation, and review of new/modified labeling texts for shared and country-specific packs
Liaise with internal departments and external partners to collect information for labelling preparation and maintenance
Create and share updated labels ready for submission packages with local affiliates
Manage and coordinate local language translations of PIL/labels
Coordinate label change workflow using validated tools/systems, including proofreading
Track, follow-up, and communicate implementation with Supply Chain and Quality support
Manage, track, and maintain approved labelling materials archives and database
Ensure changes/new creations are approved and implemented on time to meet HA commitments and compliance guidelines
Act as subject matter expert for labelling activities, perform regular training, and create/maintain local procedures
Identify and resolve labelling issues (errors, inconsistencies, conflicts)
Optimize company resource use and perform other duties as requested by management
Support PharmacoVigilance and local/regional audits preparation/execution
Track and maintain labelling history files, old versions, and current Packaging/Prescribing Information Labels
Maintain working relationships with defined countries and provide timely support
Advise business partners on MEAP local regulatory requirements
Identify/obtain required documentation and ensure content meets registration requirements
Manage preparation of registration packages, comparative tables, handle deficiency letters, safety inquiries, and label deviations
Prepare English text, coordinate translation and proof-reading for updated/translated labels
Follow-up on documentation (e.g., CPP, reference country approval letters) and ensure internal approvals
Dispatch and archive submission dossiers; coordinate labelling update submissions with affiliates

Skills

Labelling

Regulatory Compliance

Submission Planning

Translation Management

Proofreading

Workflow Coordination

Database Management

Supply Chain Coordination

Quality Assurance

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees