Pharma Labeling Regulatory Affairs Analyst / Remote Work

Position Details:
Our client, a world-leading Pharmaceutical Company in Pearl River, NY is currently looking for an Pharma Labeling Regulatory Affairs Analyst to join their expanding team.

Job Title: Pharma Labeling Regulatory Affairs Analyst / Remote Work
Duration: 10 months contract, extendable up to 48 months
Location: Remote Worker

Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan

Job Description:

Pan-Portfolio Strategy & Support Business Analyst

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 Pfizer's labeling intelligence systems (PfLEET, GDMS, PEARL).
This position is responsible for coordinating and supporting to maintenance of the Pfizer's labeling intelligence interfacing with internal stakeholders to support Pfizer'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 Pfizer'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 Pfizer's labeling intelligence systems (PfLEET, GDMS, PEARL).