Acts as the project manager for assigned projects of simple to moderate complexity.
With little guidance from the Clin Pharm Project Management leader, develops and manages project plans, timelines, communications, meetings, and other interactions to ensure project deliverables are met on time, to the expected quality, and within budget.
Typically manages multiple projects simultaneously and is expected to play a key role in ensuring cross-project synergies are realized.
Specific responsibilities • Oversee ClinPharm Subteams (CPSTs) and Protocol Concept Sheet development at the asset level, ensuring the execution of Clinical Pharmacology strategies to support program lifecycle management. • May support the CliniPharm Submission Working Group (CSWG) by developing, coordinating and managing timelines for NDA/BLA submissions, leading cross-functional matrix teams comprising Medical Writing, Data Management, Regulatory Project Management, ClinOps, BioStats, and Clin Pharm team members. • Manage submission-level ClinPharm deliverables and milestones aligned with submission strategies and the ClinPharm Review and Approval process. Key deliverables include QC/QA-ed PK data, PopPK data, E-R data, Pop PK reports, E-R reports, eSub packages, m2.7.1, m2.7.2, and other regulatory components.
Oversee the ClinPharm portfolio and operations, including developing and maintaining CPPM SharePoint sites, templates, processes, and workflow diagrams.
Essential duties and job functions • Leads simple to moderately complex assignments that enable multiple functions and teams to achieve their project objectives within targeted timelines and allocated resources. • Leverages past precedence and Clin Pharm PM best practices to advise other functions on how to best achieve their project goals and objectives. • Interacts and collaborates with other functions; key stakeholders include Clin Pharm Lead, PMx lead, BioA lead, CPPM, Clin Ops, RPM, CDM, Medical Writing, and Regulatory Affairs) • Collaborates and partners with others across Development to ensure assigned projects are completed on time, within budget, and to the expected quality.