LATAM Regional Labeling Liaison
Merck Group
Citiplaza Head, Quito, Ecuador
hace 2 días

Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skills, diversity and teamwork of an individual like you.

To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The LATAM Regional Labeling Liaison will assist the LATAM Regional Labeling Liaison Lead in ensuring the continuous improvement of a high-quality end-to-end labeling process (including labeling development, maintenance and artwork) and drive a consistent culture of quality and compliance with regards to labeling across the region.

In this role, the LATAM Regional Labeling Liaison responsibilities include :

  • Provide support to LATAM Regional Labeling Liaison Lead for decision making for regional-specific labeling issues such as extension of implementation dates for minor labeling updates (i.
  • e., non-safety and non-efficacy labeling updates), and working with key stakeholders on the assessment and recommendations of such extensions.

  • Maintain open and bi-directional communication with LATAM Labeling Champions and LATAM Regulatory Affairs staff from the different countries.
  • Being an active member of the different labeling-related Communities of Practice, to be the voice of the region within these groups.
  • Sharing of labeling best practices globally, working with the other Regional Labeling groups, to ensure continuous improvement of the labeling processes.
  • Sharing labeling-related best practices or experiences within the LATAM Region, to improve labeling performance in the countries.
  • Support in the different labeling-related initiatives to promote an earlier and better adoption from LATAM countries.
  • Triaging and assessing labeling changes in the local labels, either as a request of the local Health Authority, or from the commercial or other local departments, in order to take well-reasoned and faster decisions for the acceptance or escalation of the changes, according to the governance model of the labeling process.
  • Provide support to Regional Labeling Liaison Lead in the strategic sourcing and digital system initiatives.
  • Working across our Global Regulatory Affairs Division and our Manufacturing Division to build out the end-to-end labeling process to ensure key labeling milestones for the labeling process (i.
  • e., from signal detection to into-the-box tracking) are available and tracked into the different Regulatory-related systems (i.

    e., BWEL, ORION, Artwork Management System and other IT systems).

  • Collaborating with Global Labeling, Country / Regional Regulatory Affairs and our Manufacturing Division to ensure full global implementation in Regulatory Affairs of artwork SOPs and optimize Right-First-Time metrics.
  • Provide support for the Near Miss Investigations (Level 3 Investigations).

  • Supporting the Global Regulatory Affairs Division, Global Labeling and Regional Quality and Compliance groups with Significant Investigations / Fact Finding activities and country preparations for Audits / Health Authority inspections.
  • Ability to provide training on labeling processes as necessary.
  • Provide oversight of labeling regulation and evolution in LATAM countries (Business Intelligence).
  • Provide second person review (Quality check) in the translation into Spanish of Company core Labeling documents which are shared with the Spanish-speaking countries in the Region.
  • Under the supervision of the Regional Labeling Liaison Lead, ensures the Reference Labeling process and the Vaccines tender product process are managed and overseen in an effective manner to ensure compliance with reference labeling updates in the region.
  • The Regional Labeling Liaison reports into the LATAM Regional Labeling Liaison Lead.

    Qualifications :

    Education Minimum Requirement : Bachelor’s Degree or equivalent on Biological Sciences, with a minimum of 3 years of working experience with or within a labeling or regulatory function.

    Proficiency in the use of our internal labeling-related systems (ORION, BWEL, GLAMS).

    Previous experience within our Company or another Pharmaceutical company in Regulatory, Commercial or Medical departments.

    Required Experience and Skills :

  • Good knowledge and understanding of regulatory processes preferably in the intended region.
  • Labeling experience including labeling artwork experience.
  • Proficient use and understanding of the internal company systems used for the processing, tracking or implementation of labeling components.
  • Excellent collaborative skills and ability to work both proactively and reactively in a timely manner in a dynamic, fast-paced environment.
  • Interlocution skills to facilitate and expedite labeling process between countries and HQ teams.
  • Self-confidence to raise the voice of the region and ability to persuade on improvements that may benefit not only the region but globally
  • Good personal and written and oral communication skills.
  • Ability to assess, prioritize, and complete multiple projects, tasks, and / or responsibilities.
  • Ability to work in cross-functional and international environments.
  • Detail- and goal-oriented, quality conscientious, and customer focused.
  • Team player; good judgment and problem-solving skills.
  • Fluent written and spoken English and Spanish required.
  • Ability to work under pressure.
  • Process improvement, and compliance / quality experience.
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