Global Artwork Liaison - Paris, France - Organon

Organon

Entreprise vérifiée

Paris, France

il y a 1 jour

Posté par:

Sophie Dupont

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Description

Job Description:

The purpose of the Sr Specialist, Global Artwork Liaison is to drive the artwork strategy within Regulatory Affairs for the changes in Source of Supply (SoS) and any other technical change triggered from API and/or Packaging Sites.

As part of the Regulatory Affairs - Global Labeling structure, the Global Artwork Liaison is responsible for overseeing the E2E artwork process starting from the technical comparison documents for a SoS change, going through artwork impact assessment and markets requirements, artwork concept elaboration, and coordination of artwork mock-ups for submission and production/commercial artwork after Health Authority approvals.

The Global Artwork Liaison is accountable to ensure the artwork process is carried out as per standard timelines and prevent any delayed in implementation of changes in SoS due to artwork.

The Global Artwork Liaison builds a network of collaboration with other areas such as CMC, Country Regulatory Affairs, Regional Labeling Leads, Technical Operations, Print Coordinators at Packaging Sites, and any other artwork SME to achieve harmonization of the roll-out of changes in SoS impacting artwork for different markets worldwide.

Responsibilities in scope of changes in SoS may include, but are not limited to:

Assess the Artwork impact due to changes in SoS based on the comprehension of technical documents.
Develop concept artwork with the applicable annotations describing the impact of the change in SoS based on new source documents such as new Site artwork profile, layout, and style master; SoS updates may be bundled with other Regulatory and technical driven updates.
Global Single Point of Contact and Global liaison between Country/Regional RA, CMC, Tech Ops and other global artwork stakeholders within and outside of Regulatory.
Assess and assist with updating business CMC / Manufacturing / Quality / Regulatory procedural documentation harmonization, improvement discussions and deviations for changes in SoS with artwork impact.
Review and approve Quality Management documentation across different divisions including Supply Chain and OMS QA.
Coordinate joint action to address Market requests, enquiries, and issues.
Coordinate joint action to ensure on time implementation of new artwork with Print Coordinators, Artwork Centers, and any other artwork SME.
Drives analysis and strategy for artwork on risk development as needed with Country RA and Regional Labeling Liaisons.
Participate in Quality Issue investigations as SME and defines CAPAs when needed in conjunction with other SMEs and Q&C.
Lead the effort to simplify and reduce the regulatory artwork activities at Country RA level by creating/maintaining a global artwork hub through expansion of vendor artwork support.
Supports the collection of artwork regulatory intelligence and supports CMC with market impact assessment.

Tasks:

Artwork impact assessment due to changes in Source of Supply that includes:

Planning of changes.
Review of technical documents.
Development of concept artwork based on new profile, layout, master style, etc.
Rollout of the artwork impact summary with SMEs.
Supports the initiatives to develop Regulatory artwork requirements intelligence.
Coordinates efforts through vendors, hubs, etc to develop artwork mockups per market for submission and production of commercial artwork after Health Authority approval.
Supports the artwork implementation in the new packaging site.
Utilization of the artwork workflow management system

Skills:

Proactive motivated individual willing to drive change and innovation.
Proficient in Adobe Creative Cloud software with emphasis on Illustrator.
Ability to think critically, strategically, independently.
Problemsolving oriented, well organized, and excellent prioritization skills.
Ability to work proactively with multidisciplinary teams at all levels, driving consensus and results.
Excellent communication in English, interpersonal, and collaboration skills, and must demonstrate Organon leadership values.
Excellent written and verbal communication skills in English including ability to write clearly and concisely.
Demonstrated sensitivity and knowledge of cultural differences with experience in multicountry, multicultural environments and demonstrated success with crossgeographically based cultural collaborations.
Understanding of production artwork /printing processes and limitations.

Experience:

Minimum of 5 years in artwork related fields for packaging components, preferably in Pharma Industry or Medical Devices.
Experience in labeling, artwork and manufacturing related processes and knowledge of regulatory and manufacturing systems.

Education:

Require bachelor's degree or similar preferably in an area related to graphic design, any digital design or any health field with experience or complementary education in graphic design

Who We Are:

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