Regulatory Labeling Business Analyst

• Title: Business Systems Analyst - V
• Location: Fully Remote
• Job Duration: 10 Months Contract + (Possibility of extension)

Description:

This position is responsible for coordinating and supporting to maintenance of the Client’s labeling intelligence interfacing with internal stakeholders to support Client’s labeling portfolio in alignment with business needs and compliance standards.

Specific responsibilities:

• Coordinate the labeling universe maintenance process, including analysis and tracking of updates.
• Ensure regular data quality checks are performed support the resolution of identified issues.
• Coordinate the implementation of label tracking strategies throughout the lifecycle of Client’s products including end of label maintenance activities are performed.

Specifications:

• This role has expertise in clinical, global and international labeling and/or artwork functions and interdependencies.
• The preferred candidate will have experience with Client’s labeling intelligence systems (PfLEET, GDMS, PEARL).

Education:

• Bachelor’s Degree or equivalent
• Advanced academic qualification/degree desired, equivalent relevant professional experience will be considered.

Experience and Attributes:

• 8+ years’ experience in global/multi-national pharmaceutical environment, including direct experience either in Labeling or Regulatory Affairs role.
• Experience with Business Analytics required.
• Experience with interacting autonomously with leaders and working in a matrix team environment a must.
• Experience in interpreting and applying global and local regulatory guidance around labeling/regulatory and associated supportive documentation desirable.
• Experience in labeling and/or artwork processes preferred.
• Demonstrated track record of delivery to time and quality.

Technical Skills:

• Proven fluency with use of soft skills and negotiation skills..
• Ability to transform ambiguous situations/discussions into structured outcomes.
• Ability to partner with wide range of business stakeholders, crossing multiple divisions across multiple countries/cultures.
• Proven leadership driving highly complex projects to meet evolving business needs.
• Ability to manipulate and understand complex data.
• Ability to synthesize and communicate complex information and analyses to a variety of audiences in both verbal and written format.
• Clear and adaptive verbal and written communication skills.
• Excellent problem-solving capabilities.
• Strong facilitation and project management skills.
• Ability to evaluate and diagnose process and systems.
• Knowledge and experience with labeling or similar tracking systems.
• Knowledge of XML, regulatory tracking, document management systems, various reporting tools.
• The preferred candidate will have experience with Client’s labeling intelligence systems (PfLEET, GDMS, PEARL).