Job Description

Job Purpose
This role ensures delivery of Global/Regional/Country artwork throughout product lifecycle, including launch into markets. This role manages day to-day interactions with vendor(s) to ensure delivery of quality Global/Regional/Country artwork to timelines, including provision of regulatory pack management advice.
This role executes agreed Global/Regional/Country artwork strategy and manages multiple project assignments simultaneously as well as identifies risks associated with Labelling and packaging components.
Key Responsibilities

• Timely management and communication of documentation to support global and country/regional Artwork development and maintenance. Leveraging regulatory and packaging knowledge/experience to respond to content queries, working closely with Labelling content Leads, Supply Chain Managers and Artwork teams.
• Interface with the outsourced vendor as well as other Regulatory or GSK functions to support the delivery of market artwork, ensure consistency of processes and practices, include driving continuous improvement and best practice sharing.
• Operates with minimal supervision, making management aware of issues with high business impact.
• Efficient management and communication of other Labelling documentation as required.
• Providing support to GSK Labelling teams to help ensure quality and consistency of labelling documentation content and storage.
• Supporting Labelling processes and systems in accordance with GSK policies and procedures.
• Ensures accurate version control of documents for multiple labelling submissions and components.
• Understands publishing and HA requirements for submission of packaging components and provides labelling components for HA submissions for centrally managed packs.
• Provides additional support to GSK Labelling teams in the generation and maintenance of global and regional/country PI.
• Participation in other projects and activities, such as contributing to the implementation of changes to processes within Labelling.
• Support other labelling functions as needed (such as, Country Labelling, Business Performance, audits). Actively builds an organizational network.
• May have data review responsibilities for peers and may identify improvement opportunities for Labelling processes, policies and systems.

Minimum Level of Education

• Bachelor's degree in life sciences field or related field that is appropriate to the function.

Area of Specialization

• Life sciences, pharmacy, commodity science or other related science or technical bachelor's degree.

Preferred Level of Education

• Master Degree or equivalent experience.

Preferred Area of Specialization

• Healthcare-related regulatory pack management/artwork.

Job Related Experience (minimum requirements)

• 2-5 years of relevant experience (in pharmaceutical industry, life sciences or regulatory operations or labelling).
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner with the ability to interact with various functions.
• High Attention to detail and excellent organization and time management skills, as well as a commitment to quality.
• Ability to think flexibly to meet shifting priorities and timelines.
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

Other Job-Related Skills

• English language skills.
• Regulatory pack management experience (EU, International and/or US).
• Working knowledge of product information/labelling documentation and application to packaging.
• Experience of supporting products registered via a variety of procedures, in particular, familiarity with associated packaging guidance.
• Experience and familiarity of working within documentation databases and MS team sites.
• Familiarity with medical terminology.
• Team working skills.
• Operates with minimal supervision, making management aware of issues with high business impact.
• Ability to work carefully under time constraints and prioritize accordingly within a matrix team environment.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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Skills Required