Healthcare Regulatory Associate - Stone Cross, East Sussex, United Kingdom - Pfizer

Description

Information Management - Randomization Associate page is loaded Information Management - Randomization Associate
Apply locations United Kingdom - Sandwich China - Shanghai - Shanghai time type Full time posted on Posted Today job requisition id

Job Description:
Information Management - Randomization Associate

Individuals filling the position listed are accountable for executing the business processes required for randomization schedule generation and validation, task monitoring, blind maintenance, critical response, and procedural document regulatory compliance.

Execute critical randomization functional procedures according to standard operating procedure and business process policy.
Act as gatekeeper, and execute all directives in accordance with organizational prioritization, while maintaining the confidentiality of sensitive blinded data
Coordinate, and develop as required, metrics collection procedures, maintaining reliable metrics according to organizational objectives.

Execute record collection processes, ensure critical records are stored within COE-owned repositories, managed in accordance with external regulation and internal processes, and are protected and controlled over the long term in accordance with established retention schedules.

Execute TMF documentation and file processes according to Pfizer SOPs and policies.
Execute all documentation procedures to ensure Global Regulatory inspection readiness, audit preparation and response.
Leverage knowledge of process and system function to contribute to system requirements development, UAT and validation.
Global Regulatory and audit procedures
clinical data systems and procedures
document management business processes, including secure Trial Master File procedures in the healthcare and/or pharmaceutical industry
data quality and validation procedures
Healthcare and/or Pharmaceutical metadata and standards
~ Training or equivalent experience in Information Management concepts and practices.
~ secure document management systems
~ query tools/data extraction techniques (e.g., SQL, PL/SQL, etc.)


Training & Education:
Bachelor's degree OR extensive knowledge of working in the pharmaceutical research and development industry through in-role experience
Document management expertise
Pharma Regulatory response and inspection readiness experience
Clinical data handling and business process experience
Proficiency in handling sensitive data

Basic knowledge of pharmaceutical drug development environment and regulations.
Collaborative and capable of productivity in on-site and remote settings.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Able to work occasional non-standard business hours, weekends or holidays as required by organizational priorities and objectives.

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.

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.

We believe that a diverse and inclusive workforce is crucial to building a successful business.

As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve.

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.

Your journey with Pfizer starts here
Information & Business Tech#LI-PFE About Us
Pfizer careers are like no other.

In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives.

We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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