Compliance & Oversight Lead Manager

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

This position is responsible for business process monitoring and appropriate follow-up with colleagues responsible for taking action based on findings. This position will identify basic trends and opportunities for improvement and this role may support the implementation of business process change and applicable remediation work. This position predominantly engages with internal department staff to educate and provide support for labeling activities.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

Facilitate the GILA business process, data quality and compliance by;

·       Generating GILA project line listing & reports and facilitating Global Labeling Portfolio Lead with information necessary for effective resource management.

·       Maintaining GILA SharePoint pages and Pfizerpedia, e.g. 2nd brand tracking, GLL trackers, TA lists, etc.

·       Contributing to labeling processes via specific business cases, job aids, work instructions, etc.

·       Performing routine process and quality monitoring according to agree upon business plan and schedule.

·       As requested, support investigations for QE activities for both above country issues.

·       Analyzing system data to ensure data quality and alignment with key reports.  Actively follow up with SMEs to resolve data discrepancies contained in labeling/regulatory systems utilized.

Support continuous improvement and efficiency efforts by;

·       Monitoring process & performance and identifying trends in data acting as project coordinator for various departmental initiatives involving labeling/regulatory processes and areas for improvement.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

Qualifications

Education:

·       Bachelor’s Degree or equivalent.

·       Regulatory Affairs degree desirable.
 

Experience and Attributes:

·       Some experience in global/multi-national pharmaceutical environment.

·       Experience in Labeling and/or regulatory affairs role preferred.

·       Ability to work independently and manage multiple priorities at one time.

·       Demonstrated excellence in project management/project coordination.

·       Demonstrated track record of delivery to time and quality * Demonstrated effective oral and written communication skills * Experience in Continuous Improvement desired.

Technical Skills

·       Strong facilitation, project management and coordination skills.

·       Clear and adaptive verbal and written communication skills.

·       Demonstrated problem-solving capabilities.

·       Ability to manage medium complexity projects to meet evolving business needs.

·       Ability to manipulate and understand data with guidance.

·       Ability to synthesize data & processes and effectively summarize conclusions to project leaders/key stakeholders.

·       Knowledge of tools used to enhance communications and design processes desired.

·       Ability to evaluate and diagnose process and systems.

  
Work Location Assignment: Hybrid

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Regulatory Affairs