Mexico, Remote
**Additional Locations**: Argentina-Remote;
**Job ID** R
**Category** Administrative
**ABOUT THIS ROLE**:
Manage the Clinical Medical Controlled document (CMCD) process and procedural document portal (relational 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 Pfizer colleagues, auditors, vendors, and regulatory authority inspectors), structure, content, quality and core and end user implementation from a general and local country & functional area perspective. The responsibilities include overseeing and performing quality checks for all processes and associated content and documentation for consistency and standards and assisting process documentation designer with development, revision, maintenance and oversight of specific activities, such as mapping process flows and associated content. This job also leads the development of departmental metrics and other reporting activities; facilitates/contributes to the process evaluation and integration of acquired company and/or asset related programs into Pfizer processes; contributes to compliance and audit/inspection readiness strategies and plans; and is 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.




- Oversee support staff and contingent workers in daily activities related to the process portal, including training on process enhancements, and providing feedback and remediation.
- Enter and maintain data/information into the CMCD process and procedural document portal by collaborating with the CMCD authors.
- Independently manage the S&T; query assistant website business process and content of over 1200 questions/answers.
- Lead special projects related to process portal as requested by supervisor.
**Departmental Metrics**
- Independently prepare monthly/biannual/annual metrics, identify and evaluate metric trends; lead the review, endorsement, issue follow-up/resolution, and communication of metrics.
**Controlled Procedural Documentation Management**
**QUALIFICATIONS / SKILLS**
- A scientific or technical degree is preferred.
- Business degree and/or coursework with specific training in the following is preferred:
- process modeling, design, analysis and improvement methodologies and tools
- BS and over 7 years; MS and over 5 years, or 10 years relevant experience in pharmaceutical industry.
- Experience in process design and modeling methods, demonstrated ability to design effective processes.
- Demonstrated experience in project management and implementation techniques.
- Previous continuous improvement experience considered a plus.
- A strong working knowledge and understanding of drug development processes, database structures, relational database management software, and data analysis tools.
LI-LG4
LI-REMOTE

📌 Process and Procedural Document Lead - Fsp (México)
🏢 Parexel
📍 México