Global Labeling Specialist-Contract

Company Description

Sia Partners is a next-generation consulting firm focused on delivering superior value and tangible results to its clients as they navigate the digital revolution. Our global footprint and expertise in more than 40 sectors and services allow us to enhance our clients’ businesses worldwide. We guide their projects and initiatives in strategy, business transformation, IT & digital strategy, and Data Science.

Job Description

One of our premier clients is in need of a Global Labeling Associate (GLA) to lead, communicate, and manage tactical activities of the E2E submission and implementation phases of all labeling changes in regional and local product information and packaging to final printed packaging materials. The GLA will also lead, manage and support implementation of on-going global projects with labeling impact to the foundational markets and rest of world.

Location: Remote

W2 Compensation Range: This role will compensate $90-$95/HR/W2 depending upon years of experience, education, and relevant certifications. 

Project Length:  6 Months Plus

Responsibilities

• Manage, track assigned global projects with labeling impacts and monitor implementation worldwide.
• Interface with impacted stakeholders for the maintenance and implementation of approved labeling variations into the electronic or printed package materials
• Support GLO in providing foundational markets (Australia, Switzerland, Germany, EU and US) labels to GRA Region and ROW for NDAs, renewals, CPPs and request of labeling verification statements.
• Collaborate and manage functional SMEs on vaccines Annual Strain Update (ASU) pre- and post- activities: Northern-ASU and Southern-ASU hemispheres.
• Coordinate, manage and implement labeling assessment in RIMS, and Trackwise system for global labeling changes.
• Support pre- and post-submission labeling activities for foundational markets.
• Coordinate and manage GCC-related activities; RA Assessment and LCI collaboration with Submission Coordinator and GL Compliance
• Ensure first time quality and compliance in all aspects of labeling with detailed packages delivered in a timely manner.
• Manage and distribute English manuscripts for multimarket labels based on EU CP/MRP/DCP
• Prepare and distribute EU (MRP/CP/DCP) and US Foundational labeling package to EU- and US-dependent markets.
• Collaborate with EU-GRA Lead in coordination of labeling activities for EU CP/MRP/DCP submissions (i.e., linguistic review, national translations)
• Prepare and distribute Foundational packages to DE and CH dependent markets.
• Management and distribution of English multi-market manuscripts based on CCDS, DE and CH to dependent markets
• Prepare and distribute labeling packages to Toll markets / regions

Qualifications

• BSc Degree is preferred. BA accepted.
• 6+ years of pharmaceutical industry experience and 3+ years of labeling experience 
• Experience in regulatory/quality systems 
• Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
• Excellent oral and written communication skills, ability to manage timelines 
• Problem-solving ability and able to analyze risk and make appropriate recommendations/decisions.
• Experience working with global teams.
• Experience in regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifying issues; offering creative solutions and strategies, including risk mitigation strategies.

Additional Information

At this time, Sia Partners does not intend to pursue employment with applicants who require/will require sponsorship for work authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa, or any other non-immigrant status). Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for work authorization.  

Our Commitment to Diversity

Diversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an environment in which everyone can reach their full potential.

Our global network, DEIB@Sia Partners, brings together our people worldwide to facilitate local and global progress, focused on the following areas:

• Gender equality (global Gender Equality Index score of 91/100 for FY19-20)
• LGBTQ+