Pfizer Work Values

Daily Duties at Pfizer:

•Served as a primary contact for the Oncology clinical trial teams, attended study start-up team meetings, handled escalation of issues that arose from study teams and investigator sites •Coordinated, initiated, monitored and maintained all Investigator Initiation Package (IIP) documentation for assigned studies, and assisted in negotiating regulatory and legal documents between internal personnel and investigator sites •In-depth comprehension and hands-on experience from study start-up through study close-out and clinical trial reporting •Reviewed and edited informed consent, SOP and protocol documents •Maintained and coordinated the logistical aspects of clinical trials according to GCP, ICH, FDA regulations and relevant SOPs •Ensured regulatory compliance during clinical research studies through continuous review of changes to GCP, ICH or FDA guidelines and relevant SOPs •Created, analyzed and implemented action plans to ensure project deliverables were completed following defined procedures and developed in accordance with project timelines •Recognized by colleagues and management as a consistent high performer, maintained heavy workload and met or exceeded standards of quality for work completed •Recognized as a department subject matter expert for internal systems and processes •Recognized as a department subject matter expert for developing new processes and programs and assisted in piloting, evaluating and implementing the following processes: Form FDA 1572, Investigator Initiation Package (IIP), Informed Consent, Advertisement, One Page CV •Designed slides and presented in the Clinical Studies Operation Manager Training Program regarding the role of the document specialist •Conducted and facilitated a global training program on processing of the regulatory document Form FDA 1572 revisions, which received unanimous approval from management •Identified areas for process and technology improvement within individual’s area of responsibility and expertise •Trained new document specialists in departmental processes, systems use and SOPs; created and maintained training materials and job aides to assist in the on-boarding process •Represented document specialist group on SOP and OPD process development teams •Assisted department manager in planning, implementing and assessing work assignments for department colleagues and contractors, as well as compiled metrics for document specialist to be used in North American Monitoring Group Executive Summary •Worked with internal data capture systems to ensure accuracy of drug shipments and worked as a liaison between the sites, the study team, contract research organizations, and Pfizer managing study deliverables •Provided oversight to functional service provider vendors and clinical research organizations •Chaired the Project Associate/Document Specialist Guideline Committee, which met monthly to review current processes and identified ways to improve regulatory document processing, including maintaining guidelines and posting to Insight (Livelink) •Processed incoming requests from study teams and investigator sites to Document Specialist colleagues while serving as a helpdesk administrator; addressed all requests in an efficient and timely manner •Performed multiple administrative tasks •Tracked and ordered drug and clinical supplies for assigned studies

What they like about Pfizer:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Microsoft Project, SharePoint, Organizational Skills, Team Leader, Document Specialist, Administrative Professional

Skills

Project Management, Document Coordinator, Administrative

These are some of the questions we asked our climbers about their experiences with Pfizer: