Data & Conformance Manager, Associate

Pfizer is hiring a Data & Conformance Manager, Associate in Bogotá, Colombia. Level rates it ; you can apply on Pfizer.

Level's read on this job

Little AI ●○○○ is how Level rates this role: aI is not part of the work.
Level classifies it as a junior role.
Level lists 586 other open roles at Pfizer.
The role was posted in the last few days.

AI in this role

JOB SUMMARY

The Data & Conformance Manager focus within Regulatory Data & Conformance Management (RDCM) is to interpret, manage and ensure the quality, accuracy, and proper management of global regulatory data and conformance activities received across different geographies, functions and divisions. Ensuring key activities and regulatory systems updates are completed whilst adhering to all policies, practices and procedures. These activities ensure data integrity to enable the organization to have visibility across all functions within a products lifecycle. It is essential that all systems are clearly and accurately updated within the timelines specified in the Standard Operating Procedures (SOPs) or business process documentation to ensure regulatory compliance.

RESPONSIBILITIES

- Review and interpret the data provided by GRS to establish the system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.

- Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets

- Responsible for making updates in regulatory systems for all the CMC events upon receipt of notification of Submission and Approval evidence

- Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.

- Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance

- Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.

- Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values

- Assist in ensuring internal regulatory processes and procedures are well documented

- Support the teams in ADHOC activities including assisting presentations / review of metrics

- Makes timely decisions on straight cases within guidelines and policies

Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs

How we rate this

Data & Conformance Manager, Associate at Pfizer rates 37 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.