METAP Labelling Specialist

Job description

**About Abbott:**



Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare.

With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people.



Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.



**JOB PURPOSE AND SCOPE**



Support managing labelling activities within the METAP coverage areas to ensure activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements.

Overall scope consists of providing support to Regulatory Affiliate in oversight of all related labelling activities, primarily in:



+ Coordination of submission planning, preparation, review of new or modified labeling texts for METAP shared packs and country specific packs in collaboration with affiliates.

+ Liaison with internal departments and external partners (Third Party Manufacturers) to collect needed information enabling labelling preparation & maintenance in compliance with local market requirements.

+ Create & share Updated labels ready for submission package with local affiliate to comply with the latest approved labeling product information.

+ Manage and coordinate local language translations of PIL/labels as applicable.

+ Coordinate the workflow of the label change for local & regional labeling using validated tools & systems including proofreading.

+ Coordinate in collaboration with local affiliates the review and approval from regulatory, Medical and marketing as applicable.

+ Track, follow-up and communicate implementation with support of Supply Chain and Quality

+ Manage, track and maintain approved labeling materials archives and database.

+ Ensure that changes/new creations are approved and implemented on time to meet HA commitments and internal compliance guidelines while maintaining uninterrupted and optimized supply for operations.

+ Create and maintain local procedures & documents as needed.

+ Act as subject matter expert for labeling related activities and procedures and perform regular training as needed.

+ Identify labeling issues (as errors, inconsistencies and conflicts) between package leaflet and SmPC and take the lead to solve such issues.

+ Perform any other duties as requested by the management.

+ Optimize the use of the company resources while fulfilling the above activities.

+ Support in PharmacoVigilance Local & Regional Audits preparation & execution as applicable

+ Ensure record retention (archiving)



**1.** **Planning & Compliance Tracking**



+ Track & Maintain labelling history files and old versions of labels by retaining most current versions of Packaging/Prescribing Information Labels.



**2.

Stakeholders Coordination**



+ Maintain working relationships with defined countries and provides timely and high-quality support as per internal procedure.



**3.

Submission Execution and Compilation**



+ Advise Business Partners (Portfolio Expansion Lead, Global Labelling Group) on MEAP local regulatory requirements.

+ Identify/obtain required documentation and ensure content meets requirements for the registration of labelling changes.

+ Manage the preparation of registration packages and coordinate additional requests related to deficiency letters, safety-related inquiries and label deviations.

+ Manage the preparation of the comparative table as needed.

+ Prepare easy to read English text, coordinate translation and proof-reading for updated/translated labels.

+ Follow-up on documentation availability (CPP, Ref.

country approval letter…etc)

+ Ensure internal approval for the complete submission dossier (Affiliates’ sign-off) prior to filing

+ Dispatch and archive submission dossiers

+ Coordinate labeling update submissions with regulatory affiliates and follow-up on approval.



**4.

Coordinate the WorkFlow of Mock ups & LCR request**



In line with Global / regional/local procedures and validated tools & System.



**5.

Regulatory Intelligence & Process Improvement**



+ **I** dentify and recommend opportunities for improvement to the labelling processes, quality, systems, tools and policies.

Benchmark existing processes against external processes.

+ Implement process improvements.

+ Regularly monitor, assess, interpret new local regulations related to labelling activities and communicate impact accordingly.

+ Maintain regional labelling procedures up-to-date.



**Technical/Functional Skills Required**



+ Precision and accuracy in task execution

+ Flexibility

+ Assiduity and hard working

+ Ability to manage multiple projects at the same time and deliver results within deadlines

+ Ability to work under pressures and deadlines

+ Critical thinking and ability to challenge the status quo

+ Strong communication skills

+ Detail-oriented



**Education/Qualifications/Experience**



**Education:**



+ Chemistry, Biochemistry, Pharmacy

+ Years of experience: 1-5 years (Regulatory, Labelling, Supply chain)



+ Minimum 3 years of relevant experience in Labelling

+ Knowledge of labelling requirements procedures, policies and standards

+ Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity

+ Regional experience is highly recommended.

+ Detail-oriented, communication, compliance and process Improvement skills.

+ Proficiency in English language

+ Computer Knowledge: Knowledge of Agile system & the Office package (Ms Word, Ms Excel, Ms Power Point)



An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Required Skill Profession

Other General