Drives the overall business process, oversight, and compliance by;
- Compiling data from various source, generating, analyzing and supplying GILA dashboard, various business scorecards and compliance graphs, PSMF report etc. Crafting key messages to accompany these various reporting activities.
- Supporting BPO framework and delivering on core BPO related responsibilities
- Leading process development via translating business requirements into current and future business process.
- Creating efficiencies with technologies utilized and identifying new technologies that enable better business efficiencies, e.g. batching calculator, PRL maintenance, authoring and contributing to Labeling policies and processes via CMCDs, etc.
- Leading projects from conception through execution.
Act as primary business contact (SME) for labeling system development by;
- Work across all necessary stakeholders within and outside GRS to align business needs and expectations to
technologies and longer term technology roadmaps
- Contribute to designing and building system user requirements, reviewing configuration specifications, system record investigation/resolution etc.
- Contribute as a member of necessary system change control boards and impact resolution team
- Chair Labeling SME-IM Governance Forums
- Lead business side discussions regarding specific projects and priorities
Oversee End-to-End Labeling process, data quality and compliance by;
- Performing complex process and quality monitoring; design and document agreed upon business plan and schedules
- Creating and maintaining required labeling/regulatory quality management plan
- Participate and/or lead CAPAs, QEs and audits and inspections for both above country and regional issues in department scope
- Providing oversight of monitoring processes including submission timelines delays/rationales, content inconsistencies, etc.
- Problem solving issues with data integrity against CMCDs, supporting documents and technical expectations.
- Recommend & lead holistic, end to end quality analysis across multiple systems and processes
Drive Continuous Improvement and Efficiency Efforts by;
- Using labeling/regulatory systems to analyze data, identify improvement opportunities and propose/lead changes.
- Investigate and design new and innovative ways to solve business problems, improve processes and drive efficiencies.
- Acting as SME for various divisional initiatives involving labeling and regulatory strategy process.
- Serving as business leader of labeling/regulatory CI projects aimed to increase efficiencies, simplify, improve quality, and/or reduce cost.
- Keep informed of industry norms and evaluate against and for Pfizer best practice
- Influence industry labeling best practice via industry forums, conferences, e.g. LabelNet
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
- Advanced academic qualification/degree desired, equivalent relevant professional experience will be considered.
Experience and Attributes:
- Strong experience in global/multi-national pharmaceutical environment, including direct experience either in Labeling or Regulatory Affairs role and clinical trial role.
- Experience with Business Analytics required.
- Experience participating in audits and preparing for inspections or other quality related background desirable.
- 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 writtenformat
- Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
- Excellent knowledge of tools used to design processes and process flows, etc.
- Clear and adaptive verbal and written communication skills
- Excellent problem-solving capabilities
- Continuous improvement skills (e.g., FMEA, RCA)
- 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, document management systems, various reporting tools
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!
Continuous Imprv and Proj Mgmt