Labeling Associate (Contractor)

Dubai, UAE

Ref: HP647-1449

Job description / Role

Employment: Full Time

Our client, a multinational Pharmaceutical company, is currently seeking to recruit a Labelling Associate . You will be reporting directly to the Consumer Head of Regulatory Affairs, Middle East

This is a contract staffing role under Manpower for a period of 12 months.

Position Purpose
- The Labeling Associate is an executer of the labels and artworks plan for his/ her specified products / regions of responsibility.
- You will provide labelling expertise for and executes the :
- New products artworks development for specified product line(s)
- Preparation, follow up and revision of new or modified labels text and artworks for specified products / regions of responsibility.
- Ensure that labels changes are approved & implemented on time to meet MOH commitments and local / regional and corporate compliance guidelines.

Primary Responsibilities

Technical:
- Preparation of new labels and artworks for Companys products.
- Updating current labels.
- Identifying labeling issues as: errors, inconsistencies, conflicts, etc., between package leaflet text statements and reference documents.
- To identify each project scope as - but not limited to - which SKUs / markets are affected , number of artworks to be developed , need to generate bar codes , starting artworks to be used , timeline agreement & tender requirements.
- Coordinate with Regulatory team to generate barcodes.
- Responsible to generate project number to be used in all related forms for that specific project
- To investigate if any other changes needed to same product to be included in the requested project.
- To document and update project specific details in Annual Labeling Plan Sheet.
- To follow up with new SKU requester on status of Source Request / Product Request Form system approval.
- Responsible for artwork text translation either internally or to coordinate via 3rd party vendor.
- Responsibility includes getting quotation, following its approval, communicating approval to vendor and getting translated text on agreed timeline.
- Generating medical approval.
- To annotate starting artwork files with all required changes in a clear specific way.
- To generate and route for approval the Artwork & Labeling change request form. It is Labeling Associate / Coordinator responsibility to get all stakeholders approval before process artwork changes.
- Open Companys Artwork Request on artwork system which includes - but not limited to - annotated artworks , reference documents , project description , planned implementation criteria , related markets and SKUs
- Facilitate the approval of write off costs by Logistic & Regulatory team of the market.
- Follow up with the plant to get Companys Artwork Request Approved on the system.
- Follow up with Studio to develop agreed artwork within specific timeline.
- To review the entire received artwork.
- Using artwork check lists whenever needed.
- If any new changes received during the revision process and before project closure, it is Labeling Associate / Coordinator responsibility to document the new request and inform all stakeholders.
- Preparation of artwork comparison table to be sent with approval form for Companys internal approval.
- Preparation and routing of approval form to internal stakeholders. It is Labeling Association / Coordination responsibility to ensure form is totally approved.
- In case of Nutrition artworks, to prepare English translation of non-English text to be submitted with final approved artwork to the head quarter. May use distribution markets teams or 3rd party vendor for revision and translation for other non- English languages.
- In case of Nutrition artworks, to address all head quarter comments , amend changes as agreed and repeat approval process to reach agreement of final approved artwork version between both market and head quarter.
- To confirm implementation criteria with Regulatory team and communicate this to all stakeholder including - but not limited to plant, medical, logistics and marketing if needed.
- Responsible to amend artwork as per BOH received comments
- Responsible to follow up with Regulatory to get all markets approvals in case of shared packs to ensure one implementation as per related region/ markets.
- Responsible to apply system approval and inform all internal stakeholder of implementation timeline using notification memo.
- For tenders, work closely with supply team to get specific artworks approval and implementation as per tender agreement.
- Archiving all project documents which includes - but not limited to - final artworks, approvals, forms, reference documents in both soft & hard copies.
- Whenever artwork is requested to be implemented at risk, to generate at risk approval form and route for approval. It is Labeling Associate /Coordinator responsibility to ensure form is filled correctly, approved and communicated to all stakeholders. Labeling Associate / coordinator works with Regulatory to inform all stakeholders whenever BOH approval is received.
- Labeling Preparation, Submission and Approval:
- Prepares Quality labeling documentation and facilitate submission within planned affiliate timelines as directed by Regulatory team.
- Ensure submitted product labels fully meet the local / regional and corporate compliance guidelines.
- Understand the local / regional regulatory guidelines and requirements for specified product line(s).

Labeling Compliance:
- Ensure that all marketed products in region are in compliance and meet local / regional and corporate regulatory requirements.
- Ensure local / regional label development will meet local / regional and corporate compliance guidelines and regional artwork development SOP.
- Tracking of labeling commitments.

Labeling Support:
- Provide current / updated labels & artworks to internal stakeholders whenever needed.
- Provide reference market artworks whenever requested.
- Update labeling archives either soft or hard copies.
- Track reference markets documents & artworks and inform Regulatory team.

Requirements

- Details oriented with Quality aspiration
- Organization and Planning skills
- Decision making capabilities.
- Ability to handle multiple Projects and interact with a variety of business components
- Leadership skills
- Good oral and written communication skills
- Tolerance for stress, Self motivation.
- Time management
- Analytical skills, accuracy and reliability
- Initiative, networking
- Teamwork/Collaboration
- Appreciation of cultural diversity.
- PC Minded (Word processing, Excel, Power point , Adobe acrobat and ability to handle database)
- Qualifications (i.e., preferred education, experience, attributes)
- Scientific University Degree, Preferred Pharmacy Degree.
- Fluent in Arabic and English is an advantage.
- Labeling / Regulatory experience is an advantage

About the Company

We lead in the creation and delivery of innovative workforce solutions and services that enable our clients to win in the changing world of work.

ManpowerGroup powers the success of many of the world's most dynamic organizations. We deliver innovative workforce solutions that enhance competitiveness, increase efficiency and spur productivity. Combining global reach with local expertise - 3600 offices in over 80 countries - we know the changing world of work and bring a deep understanding of the companies we work for and the industries we service.

ManpowerGroup entered the Middle East in December 2007 after acquiring local company Clarendon Parker, thus bringing 15 years in-depth local knowledge combined with a global footprint and industry shaping expertise and thought leadership. Manpower Middle East supports clients in the Middle East and North Africa regions. Our business is aligned to key skill specializations to ensure our clients requirements are met by expert and knowledgeable consultants that understand your industry and role requirement.

Our consultants are experts in finding the right talent across all industries in a broad-range of occupations including: