Medical Operations Processes Subject Matter Expert

ROLE SUMMARY

The Pfizer Global Medical Operations Platform Services team supports operations across Grants, Research Collaborations, Publications, Transparency, Expanded Access, and Technology processes. We are seeking a highly skilled and experienced Medical Operations Process Subject Matter Expert to join our team. In this pivotal role, you will be responsible for recommending and initiating process changes to drive continuous improvement in response to evolving business requirements, regulatory changes, and adjacent processes.

The Operations Subject Matter Expert (SME) works as part of a highly matrixed team, interacting with team members within Global Medical Grants and Partnerships (GMGP) and Global Medical Operations Platform Services (GMOPS), as well as with stakeholders from inside and outside of the company to ensure Grant Management processes are managed in an effective and compliant manner. The SME will 1) Provide system requirements support, 2) Lead business process optimization initiatives, 3) Serve as escalation point of contact within GMGP/GMOPS for operational queries that arise related to processes, and 4) provide subject matter expertise in other areas (e.g., drug supply, competitive programs, safety, publications, transparency, expanded access, etc.) as requested.

• Facilitate resolution of complex issues, including drug supply and safety.
• Assist with processes related to budget forecasting and tracking of payments.
• Assist with identifying and managing emerging changes and opportunities, driving iterations of process and system changes.
• Serve as Project Manager for all assigned programs including competitive grants.
• Closely monitor process to ensure operational efficiency and raise anomalies to the team, including, but not limited to, reviewing monitoring reports and flagging overdue actions.
• Organizing and managing various document repositories and communication/collaboration channels, as needed/requested.

• Engage with Pfizer Headquarters and Regional/ Local colleagues for management of GMOPS processes.
• Support internal and external stakeholders in using Pfizer's operations systems and dashboards, including, but not limited to, providing training on system functionality, assisting in troubleshooting issues, etc.
• Facilitate escalation of operational issues with internal stakeholders.

• Adhere to applicable SOPs, written standards, working practices, and implementation guidelines for the GMOPS processes and contribute to their development.
• Serve as a trainer for new team members on policies, procedures, and systems.
• Identify training opportunities for internal stakeholders including Medical Affairs, Operations, AND/OR Research Unit business(es) and executes training plan, such as GMG Dashboards, grant system, and budget processes.

• Assist team with Outcomes Assessment by generating customized ad hoc reports of data points not captured in dashboards for both internal and external materials, such as, internal presentations, brochures for external audiences, and reports submitted to government agencies.

• Work closely with team to set up the timeline for each Request for Proposal (RFP), develop and execute the communication plan.
• Manage the Expert Review Panel: contracting, user access, reviewer instructions, conduct training calls as needed, and schedule review meetings for all competitive grant program types.
• Coordinate with GMG Communications Lead to plan and execute communications strategy in conjunction with BU Communications Lead.
• Compile review panel feedback and coordinate with team to disseminate to applicants.
• Assist with review panel meetings.
• Partnership Management:
• Execute collaboration process (e.g., FRF process) and ensure collaboration agreement in place for partner-projects/RFPs.
• Involved in discussions with new partners/new initiatives from the start.
• Coordinates payments to Partners and Sunshine forms distribution/collection.

• Assist the operations team and key stakeholders with additional activities, as requested. Such activities can include, but are not limited to:
• Assisting leadership in the planning process with internal stakeholders including Medical Affairs, Clinical Development, AND/OR Research Unit business(es) to ensure alignment with the overall asset/business development and lifecycle plan.
• Assisting leadership with planning, including identifying appropriate Partners/Collaborators and options for execution, risk management, internal/external communication, and stakeholder management strategies.

• Work closely with Business Process Owners of relevant SOPs to implement and communicate process updates
• Review and maintain various document repositories and communication/collaboration channels, such as, process guidance documentation, agreement templates, and Teams channels
• Provide support during corporate audits and ensure remediation plan(s) are developed
• Represent Medical Operations team on any continuous quality improvement projects related to the programs such as the development and implementation of a new systems.

• Serve as the backup for drug related submissions and queries globally for relevant operations
• Partner with key Global Clinical Supply (GCS) colleagues to establish high level supply chain tactics to ensure appropriate supply is available to support research across all Therapeutic Areas.
• Provide key input in review processes giving feedback to teams related to availability/feasibility of providing drug supply as requested by investigators.
• Issue guidance with GCS and Pfizer Global Supply (PGS) and ensure appropriate documentation is provided to sites for regulatory submission.
• Monitor study milestones and timelines to ensure adequate drug coverage for duration of the research studies.

• Oversee the user access request process for the assigned Pfizer Medical Operations systems - review access requests, determine the appropriate level of access required and work with Business Operations to implement.
• Coordinate with stakeholders in GMG, GMOPS, the system vendor(s), and Digital to review the process for system workflow changes/customizations and to manage the logistics for such implementations.
• Work closely with platform integrations team to help document, test, and validate system enhancements.
• Monitor and respond to system-related queries sent to the GMG Mailbox.
• Oversee colleagues (through matrix model) in Wuhan, China that provide transactional support for the system. Provide guidance, work instruction, and feedback as necessary.

• Serve as main point of contact within GMG for any Safety related queries.
• Partner with Safety colleagues to manage any safety reporting deviations, which includes participation in scheduled Pharmacovigilance Policy Committee meetings, as required.
• Work closely with internal safety contacts to stay abreast of current policy and procedure as it relates to reporting Serious Adverse Events for research.

• Bachelor's Degree and strong experience required, or other relevant degree and extensive experience
• Master's Degree in a clinical background a plus
• Experience in Independent and collaborative research, quality improvement, Continuing Medical Education, Continuing Education and/or Continuing Professional Development and global experience.
• Strong communication skills; consulting skills; trusted advisor; healthcare education/quality improvement expertise; political savvy; problem solving; process management
• Extensive experience and knowledge of Pfizer's independent grants and/or research collaboration processes and programs is preferrable.
• Strong knowledge of relevant Pfizer Therapeutic Area(s), subject matter expertise in grants, collaborations and partnerships, and international experience are desirable
• Capable of working independently on multiple projects with ability to prioritize tasks and meet strict deadlines
• Demonstrated effectiveness in working in a multidisciplinary, matrix team situation, and demonstrated ability to manage change.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Excellent organizational skills
• Commitment to process improvement