1+ months

Global Clinical Supply Business Process Support Specialist

San Jose, CA 95123
**Role Summary:**

Provide business process support for Global Clinical Supply operations on projects relating to business process enhancement,

quality compliance monitoring, quality investigations, program/protocol management and continuous improvement in the context of procedural documentation development and redesign (policies, standards, standard operating procedures (SOPs)), communications, training development, monitoring, data analysis and development and other relevant supporting tools and documentation.


SOP and Process Support

Work in collaboration with subject matter experts in the development, revision, process mapping, implementation and maintenance of procedural (policies, standard operating

procedures and supporting documents) and training documentation related to Global Clinical Supply

Facilitate procedure redesign and related development and provision of training documents in accordance to established plan while engaging relevant SMEs and stakeholders

Evaluate procedural documentation against evolving industry/regulatory requirements and expectations, audit/inspection findings, business needs, changes in industry standards and client feedback and trends, including making recommendations for changes when necessary

Manage queries and deviations from the organization related to assigned policies/SOPs, and support SOP revisions/reformatting

Quality Systems Support

Support the review and trending of relevant Quality Events (SQE/QTS) to identify potential risk indicators and mitigations

Work across GCS functional lines and QA to coordinate investigation documentation in quality system. Monitor investigation record progress driving to due date and escalating when appropriate.

Support inspection readiness activities through data assembly, as directed

Portfolio and Systems Support

Provide enhanced system support for reporting (i.e. Spotfire, CT-FAST, etc.) Including Spotfire (visualization support, maintenance and development) and SharePoint (support, maintenance and development)

Support Blind Review Board (BRB) efforts to streamline data, such as developing a single-entry point that serves as BRB discussion substrate, TPB tool and knowledge management repository

Monitor large and/or complex programs/protocols and initiate all system and/or documentation to enable clinical supply processes to maintain clinical supply at depot/site

**Degree Requirements:**

A minimum of a BA or BS in related field is required.

**Required Experience/Skills:**

2-5 years' experience in process design and documentation of pharmaceutical business processes

Training or experience in safety, regulatory, medical and/or clinical supply process training development, delivery and/or implementation

Ability to work in and/or facilitate multi-phase complex projects with multiple contributors/collaborators, facilitate cross functional teams, optimize subject matter involvement, and interact at all levels in a matrix environment

Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills

Ability to adapt to changing situations and work well under pressure

Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for

process design and mapping; reporting (Spotfire); and systems for document management, publishing,

communication, and learning management

Understanding of the fundamentals of electronic publishing of procedural documents

Strong verbal and written communication skills

In-depth understanding of pharmaceutical business processes and regulations, guidelines and industry standards for compliance

Proficient and trained in using root cause analysis tools to drive quality investigations to appropriate closure including remediations as required

Proficient and trained in using Human Performance tools, Pfizer tools preferred

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

Research and Development


Posted: 2020-04-03 Expires: 2020-08-05

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Global Clinical Supply Business Process Support Specialist

San Jose, CA 95123

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