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JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.

• Providing basic or advanced analytics and modeling expertise to enable understanding of Pfizer’s clinical trial performances (quality, speed, cost)
• Supporting development of clear process models depicting Pfizer processes by maintaining process procedure documents
• Tracking and reporting compliance with regulatory commitments or established SOPs/processes
• Maintaining training content for Pfizer functional staff and reporting compliance with training commitments
• Tracking and reporting against compliance with commitments to Regulators (if applicable)

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

Metrics Reporting

• Collecting/extracting quality/compliance related data from various sources
• Performing basic analysis using tools such as Excel, Spotfire, etc.
• Producing reports, dashboards in Excel, PowerPoint, Spotfire etc. for various customers across the organization

Compliance Tracking

• Tracking completion of required activities by responsible parties across the organization
• Following-up with responsible individuals to remind/notify regarding actions needed and timeframe for completion and/or determine if actions have been completed by due date.
• Maintaining information in tracking tool in a timely manner and generating reports as needed.

Process and Procedural Document Management

• Provide support on the process mapping, implementation and maintenance of procedural documentation (policies, standard operating procedures and supporting documents) related to Pfizer clinical, medical, safety, and/or regulatory processes.
• Review the process and procedural documents by following internal processes and established standards within timelines
• Support document lifecycle within the electronic repository to maintain a state of inspection readiness

Training & Compliance Support

• Curriculum Administration
• Curriculum Reporting
• Course and Curricula Query Management
• Training Site Maintenance
• Professional Records management (Curriculum Vitae, Organizational Charts, Job Descriptions)

Continuous Improvement for Operational Process Procedures

• Support/drive technology and continuous improvement initiatives

General

• Provide on-boarding training to new team members on procedures and policies related to various areas
• Serve as mentor to other team members in daily work to ensure they have technical knowledge and experience to work with global and local partners
• Serve as subject matter expert (SME) for key processes, systems and related tools
• Serve as the point of contact for global in the corresponding areas

• Perform routine quality checks on team’s deliverables and identify quality trends

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.

• Training in current information management concepts and practices.
• Knowledge of document management practice and business processes in the pharmaceutical industry, including an understanding of the drug development process.
• Knowledge of document management systems, databases, business process management and electronic workflow/routing tools, regulatory submission and tracking systems.
• Is able to proactively initiate actions to ensure timely delivery of quality products
• Able to develop, maintain, and use project plans
• Factors an understanding of departmental, team, and business line goals and Pfizer values, when executing tasks
• Understanding customer requirements and estimating timelines for delivery

Is able to lead multiple small projects in various stages simultaneously. May coach and mentor others

Education

• Bachelor’s degree or equivalent in biological sciences, health sciences, computer sciences, informatics, business, etc. Advanced degree is desirable.

Experience

• 3+ years of related technical/business experience is desirable
• A solid understanding of the Microsoft Office suite, with advanced knowledge of Excel
• Experience with data processing and analysis techniques/tools (e.g. SQL, VBA)
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns. History of achievement in building strong customer relationships
• Good verbal, written communication and presentation skills
• Demonstrated to perform in a cross-functional environment
• Ability to interact in a professional manner and build strong collaborative relationships within internal Pfizer teams
• Understands concepts of information management with emphasis on document and records management.
• Makes good decisions in a timely manner based on analysis, experience, and judgment, even with incomplete information or under time pressure.
• Takes personal responsibility for own work, pushes self and others to exceed goals and deliver results.
• Technical aptitude with software used in the assembly, publishing and tracking of regulatory submissions.
• Knowledge of Document Management in a regulated environment.
• Mastery of processes, tools and techniques for planning and monitoring projects to established deadlines.
• Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format.
• Experience with driving change across multiple organizations while exhibiting regulatory knowledge and awareness, technical competence, sound judgement, and a professional demeanor.

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

Reports to Curriculum and Document Management Team Lead

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.