Mallinckrodt Pharmaceuticals Senior Specialist, Value Evidence Translation and External Research in Seattle, Washington
Job Title Senior Specialist, Value Evidence Translation and External Research Requisition JR000013465 Senior Specialist, Value Evidence Translation and External Research (Open) Location Field Based Location - USA082 Additional Locations Bridgewater, NJ Job Description Summary The Senior Specialist, Value Evidence Translation and External Research reporting to the Sr. Dir., Value Evidence Translation and External Research, is a critical operational resource for supporting the activities of the Evidence Generation & Data Sciences Department. The primary focus of this position is to provide support for implementing the externally sponsored research (ESR) program: investigator-initiated studies, external collaborative research, and medical ed. grants. Additionally, responsibilities may include operations support for the Evidence Generation & Data Sciences Department as needed in coordination with R&D operations. Principal Responsibilities Participates in department strategy to provide clinical evidence needed for healthcare decision-makers. Work with internal stakeholders and EGDS to identify and prioritize external research opportunities. Responsible for execution of external research projects while adhering to budget, scope, and timelines. Support external research agreement negotiations to ensure efficient and timely processing of contracts. Ensure operational aspects of the studies being conducted are in accordance with all relevant ethical and government standards, Good Clinical Practice (GCP), and standard operating procedures. Build and maintain relationships with medical education organizations. Communicate with medical ed. organizations to identify issues or barriers related to grant requests. Support for the Value Evidence Translation and External Research group including purchase order generation, invoice and contract processing, tracking of budgets, and addressing invoice issues. Will develop and generate reports to inform on the status of investigator-initiated studies, external collaborative research, and medical education grants initiatives as well as provide support in liaising with procurement and legal on contracting, opening POs, and resolution of study site issues. Maintain contracting, externally sponsored research (ESR), medical education, and budgeting trackers. Collaborate with Procurement to facilitate processes of establishing agreements with external parties. Serve as administrator for online grants management portal for ESR studies and medical ed. grants. Review and approve, reconciliation reports, payments, and refunds for medical education grants and milestone payments related to ESR studies. Coordinate with R&D operations on clinical supply process for immunology and critical care products. Maintain database of vendors and consultants related to departmental projects. Evaluate & develop process improvement initiatives to reduce study start-up time and budget management support; identify opportunities to improve operational efficiency for the organization by applying a continuous improvement mindset for key processes. Liaise with external vendors and grantees, and process required documentation as needed. Operations support as needed for EGDS may include developing and consolidating performance metrics, key performance indicators and related reports. Lead development and maintenance of EGDS procedures to ensure compliance with policies. Develop agendas, minutes, and presentation templates for team/internal business partner meetings. Minimum Requirements Experience / Skills: Bachelor\'s degree required. An advanced degree (masters) in a related field is preferred. Minimum of 3+ years of pharmaceutical experience required. Demonstrates Operations mindset with general knowledge of critical business operations capabilities.