Job Description

The position sits within the Vaccine R&D Research Informatics organization where the qualified individual will utilize knowledge of informatics, laboratory testing, clinical research operations, and GxP regulatory processes to lead a small group of system analysts focused on laboratory information system support. Within this role the individual will be assigned work by the Informatics Operations lead and will have the responsibility of ensuring information systems are up and running (i.e. first line support, administration, and minor enhancements). The individual will routinely partner with scientists, analysts, clinicians, engineers, architects, and various stakeholder groups (like Sample Management, Robotics, and External Partner Labs) to ensure their support needs are met day-to-day for clinical testing, complex epidemiology, exploratory research experimentation, and in-vivo assays. A background in basic computer programming, creating complex spreadsheets to track data, people management, help desk management, and/or a strong expertise in computer/information systems is expected.

The work is fast paced and the number of users, labs, and amount of data (especially with the success of the COVID program) continues to grow. The suite of software to be supported includes: LIMS products, custom written SAS programs, R-shinny apps, and one-off applications built in new technologies. Although not a programmer, coordination and collaboration are at the center of the fast-paced role, and the individual will have to use best judgement to juggle emergencies, nice-to-have requests, and broader needs across many stakeholders, partners, and technical analysts. Specifically, the individual will be responsible for: managing a small team of direct reports (plus potentially some consultants), triaging incoming customer requests and prioritizing accordingly, scheduling support personnel availability around business demands, reviewing/summarizing daily ticket reports, running support information/how-to meetings, and holding various status-update meetings both internally and externally to Pfizer. Meeting deadlines and milestones is critical to the success of Pfizers vaccine portfolio with extreme care and dedication often required at major study milestones. Work will be expected to be performed mostly independently, with guidance around high-level expectations, and success will be driven by the individuals organizational skills and collaboration across project teams.

Finally, the Informatics Support Manager must have a strong understanding of SDLC and software validation. It will be expected that s/he will also come up to speed quickly on the change management activities and required compliance activities. Many compliance documents (e.g. requirements, test scripts, project plans, risk assessments, change controls, etc) related to SDLC or system administration are authored, reviewed, approved, and shepherded along by the support team, with this individual personally authorizing and/or leading activities.

Work is performed under strict compliance and SOP guidelines, with attention to detail being critical. Proactive communication with both customers and fellow Research Informatics colleagues AND a passion for innovating is needed to succeed in the role. Work will occur on-site although end-user support of external partners may be required, with travel needed on rare occasions.

PHYSICAL/MENTAL REQUIREMENTS

* Under guidance of supervisor, collaborate with other informatics colleagues and architects to ensure support activities are meeting short-term and long-term client needs.
* Manage a small team of direct reports, plus potentially consultants, tasked with first-line support, administration, and minor enhancements of systems.
* Ensure a robust support process is in place to provide emergency support for end-users and manage overall support process.
* Identify system bugs/performance gaps that may require large development projects and communicate information accordingly to System Engineers and Architects.
* Provide operational metrics around various support activities from analyzing daily ticket reports.
* Hold support stand-up meetings to ensure tickets are being handled timely and documented correctly.
* Lead, and collaborate as appropriate, in the validation of computer systems or hardware processes.
* Author SDLC/validation technical documents and other change management documents as appropriate, and ensure a robust process is in place for their archival.
* Maintain detailed notes for assigned tasks, write departmental SOPs, and maintain any technical paperwork or forms as required.
* Complete any assignments associated with external labs and ensure external partner labs can securely analyze and/or transfer data associated with any assigned projects.
* Assign tasks to, establish milestones for, and mentor direct reports; closely supervise consultants tasked with various workload and deadlines.
* Mentor junior informatics personnel and partner with consultants when assigned.
* Maintain highest minimum compliance required by regulatory standards.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

* Bachelors Degree with up to 12 years experience or Masters Degree with a minimum of 9 years experience.
* Computer Science, Information Systems, or Life Sciences related degree plus tangible, work experience.
* Experience working with or as Laboratory Analyst, Data Analyst, Sample Manager, Systems Analyst, Clinical Project Manager, and/or Clinician.
* Prior extensive knowledge of LIMS or similar system required, especially as admin, super-user, or programmer.
* Experience with SDLC and regulated documentation (beginning-to-end) required.
* Experience within GxP process and with regulated documentation (including system documentation).
* Expertise within the pharmaceutical or R&D environment.
* Experience managing people directly or at a minimum indirectly.
* Strong oral and written communication skills.
* Able to juggle various activities with varying priorities and complexity simultaneously.
* Expertise within the pharmaceutical or R&D environment.
* Experience with designing, developing, creating reports, and/or querying databases preferred.
* Experience working with outside laboratories and in establishing data exchanges preferred.
* Operational experience within regulated laboratories possibly running assays.
* Project management and supervisory experience is a nice-to-have.

Other Job Details:

* Last Date to Apply for Job: February 15, 2021
* Eligible for Employee Referral Bonus: YES

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Sunshine Act

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EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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