SOP & Training Specialist

Role Summary

Responsible for ensuring high quality execution of controlled procedural documentation management used for the conduct of business in clinical, medical, regulatory, safety and quality assurance organizations in compliance with regulations, laws, company policy and best practices.

Job Responsibilities

Controlled Procedural Documentation Management Responsibilities 

Review Local Procedural Documentation:

• Reviews global procedural documents familiarize with updates/changes
• Conducts central review of local procedural documents to determine if they are in compliance with the global procedure (impact analysis)
• Liaise with local procedural document authors to provide feedback on the central review outcome
• Documents outcome of central review

Periodic Procedural Document Assessment:

• Coordinates automated notifications to authors of impacted local procedural documents that periodic assessments are due
• Completes quality review of periodic assessments and liaise with local procedural document authors to provide feedback
• Tracks the status assessment completion to ensure implementation and compliance
• Issues escalation notifications to local authors who are non-compliant with periodic assessment requirements

Quality Control of procedural documents:

• Performs quality control checks for global procedural documents, by following internal processes and established standards within agreed timelines, including prioritizing multiple tasks for timely  completion
• Performs quality control checks of information in the process management relational database. 
• Acts as a subject matter expert for established documentation standards and internal processes for consistency and compliance within a controlled regulatory environment, including providing accurate guidance and information to global procedural document authors
• Assist with documentation life cycle within the Global Document Management System (GDMS) and process management relational database to maintain a state of inspection readiness.
• Provides other documentation management and assistance including, but not limited to GDMS searches, metrics, technology initiatives and process improvement projects

Process Management Relational Database: 

• Adds data/information into the process management relational database (i.e., a database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides the business access to internal colleagues, auditors, vendors, and regulatory authority inspectors) by collaborating with the SOP authors
• Completes data quality checks, periodic and ad hoc reviews of the process management relational database content including follow-up on resolution of potential content discrepancies.
• Assist the following: running of departmental metrics and other reporting activities; provides advice on process enhancements and continuous improvement, assist and resolve any questions about or issues arising from the Process portal, partake in user acceptance testing of new versions of the underlying portal management software or resolution of technical issues.

QUALIFICATIONS / SKILLS

• Minimum of a Bachelor’s degree or equivalent
• Demonstrated strong technical or digital skills in use of digital systems and new software
• Experience with design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical), or equivalent, such as experience of writing communications or training materials, intended for customers, or experience with process improvement projects and/or implementation of business process change management
• Experience of completing quality control review of pharmaceutical business process documentation (safety, regulatory, medical and/or clinical), or equivalent, such as quality control review of other types of documentation, training materials, presentations, communications or reports
• Experience of database maintenance, such as data entry, running reports and conducting data quality checks
• History of achievement in a customer service role with demonstration of meeting customer needs and concerns

Organizational skills

• Can work independently to deliver high quality work within agreed deadlines
• Ability to manage multiple projects and adjust priorities as needed

Communication skills

• Can interact at all levels within a matrix environment, globally and locally
• Strong English communication skills (verbal, written and listening) with ability to use a variety of communication tools and techniques to explain difficult issues and work to establish consensus

Administrative excellence

• Evident attention to detail
• Ability to maintain accurate and timely records

Decision making and problem solving

• Can adapt to changing situations and works well under pressure
• Ability to make decisions based on pre-set guidelines and procedures
• Ability to recognize issues and work within the team to resolve problems

Technical proficiency

Required:

• Demonstrated technical aptitude with use of new software and digital systems
• Demonstrated proficiency in use of MS Office Suite, including Teams

Preferred:

• Tools for process design and mapping, document management, database management, publishing, communication; familiarity of the fundamentals of electronic publishing of procedural documents.
• Experience of working with a controlled documentation management system and industry standards for compliance

Business Knowledge (preferred):

• In-depth knowledge of pharmaceutical business processes (i.e., safety, regulatory, medical, clinical trials and/or enterprise quality management system) and regulations, guidelines and industry standards for compliance.

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!