The
support area of Non-Pfizer sponsored research grants including but not
limited to:
? Reviews incoming Non-Pfizer sponsored research requests and
documents for accuracy and completeness; enters requests into research
management system and prepares required correspondence to external requestors
& Pfizer colleagues, such communications to investigator, Review
Committee members, Field Based Medical, Regional, or PCO
colleagues.
? Manages distribution of study related documentation,
preparation of meeting agendas, and assists with scheduling review meetings or
due diligence review for Non-Pfizer sponsored research programs; contacts
requestors for missing or requested documentation, as directed by CRC Liaisons
and /or IIR Program Managers.
? Manages financial transactional details as well as drug
supply requests (i.e. generating drug supply forms) based upon executed
contract and study milestones; works with IIR Program Managers / CRC Liaisons
and Pharmaceutical Sciences Supply Chain Coordinators to ensure clinical supply
forecasts are up-to-date and supplies are available as required.
? Assists regular study oversight activities such as
generation of requests to investigators for enrollment sweeps and study
progress updates, forwards documents to appropriate reviewer and keep the
research management system updated.
? Maintain expertise of Non-Pfizer sponsored research process
and policy, assists PCO colleagues who are completing the submissions in
research management system to address missing information and ensures
compliance to Pfizer’s policies on Safety Reporting, FCPA, HCP and Privacy (as
required).
? Uploads final deliverables received from requestors and
closes completed studies in the research management systems.
? Assists CRC Liaisons or IIR Program Managers with status
report, queries and other logistic support as required.
? Contributes to process and technology improvement projects
within areas of responsibility, as requested.
The support areas of IGLC program including not limited to:
? Perform compliance check of organizations against internal
and external watch lists (such as OIG); check promotional speakers (EZspeak,
iMAS); review potential external review panel nominees against multiple
database (e.g., EZspeak, CAL); verify requestor accreditations (e.g., ensure
accredited org is ‘requesting org’ for grant request; obtain supporting
documentation when accreditation is activity-based).
? Obtain IRB approval/exemption documentation for Quality
Improvement grants (when applicable); check PI against multiple databases
D&I Research (e.g., CAL, INSPIIRE for CRC, and other external
references).
? Asist financial payments for all IGLC programs, identifies
existing, valid vendor IDs or creates them when necessary in Ariba/SAP. Ensure
current W8/W9 form obtained and completed appropriately. Resolves payment
process issues, initiates reissuance for lost checks, resolves technical issues
(SAP, GMS), and follows up with GFSS as necessary.
? Maintain and track grant management system access for both
internal and external individuals. For Pfizer internal individuals, ensure
required training is appropriately assigned in P2L. For external individuals
(such as ERP member, RFP partnerships), obtain user access agreement as needed.
? Periodically pull program related information form grant
management system and posted on Pfizer home page and internal Share Point site
using populated templets and formats to meet stakeholder needs.
? Participates in any grant monitoring activities (e.g.,
follow-up on milestone data, outcomes data). Refreshes reports; distributes to
specific DLs and/or posts to IGLC SharePoint/intranet per set schedule.
? Promotes consistency and standards with internal processes
and deliverables; performs QC reviews according to relevant SOPs and job aides;
assists in training others and maintaining training documents; assists in
metrics compilation and raises potential compliance risks.
? Assists ILGC manager in ensuring the compliance of all IGLC
systems and processes with internal and external compliance requirements,
policies, and guidelines; provides support during audits.
? Coordinates with Pfizer country offices and regional
colleagues to provide operational support as required to execute IGLC global
strategic initiatives.
任职要求：
Bachelor’s
degree (BA, BS) required with preference for a focus in science, healthcare or
related field. Graduate in 2018.
Good written and oral English skills, Japanese fluency highly desired.
Operational experience in clinical trial management, educational grants or
healthcare industry (pharmaceuticals, life sciences, and medical).
Knowledge of IT systems/software for database maintenance and document
management.
Demonstrated effectiveness working in a multidisciplinary, matrix team
situation, and demonstrated ability to manage change and diversity.
Good understanding of multiple disciplines (e.g., Healthcare Compliance Law,
Regulatory, Drug Supply, Clinical Study, Medical Affairs, Medical Educational
Grant, Publication development, Project and Financial Management) and
organizations (e.g., Pfizer Country Offices and Regions)
Experience with various Pfizer processes/systems/functions: MAPP (FCPA), Ariba
SAP reporting strongly preferred.
Developed customer service skills and team work spirit.