The Program Manager, CMC Dossier Management assists with the development and oversight of Chemistry, Manufacturing, and Controls (CMC) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. Regulatory submission content plans, source document maps, internal audit plans (e.g. QDP) and timelines are created using standardized project management tools and processes. Responsibilities include monitoring the progress of regulatory submissions deliverable against timelines, mapping and tracking source information which support regulatory submissions sections and maintaining accurate rosters.
- Provide dossier support to CMC projects team, including creation and maintenance of content plans, source document maps, rosters, and timelines. Supports the maintenance of multiple project plans in collaboration with CMC RA and functional area leads; assists with the identification, monitoring and analysis of business risks. Recognizes when corrective action and planning are necessary and conducts root cause analyses (escalating recommendations to Program Managers/CMC RA leads/Functional Area leads). Supports functional managers to ensure accurate resource estimates.
- Skilled in coordinating diverse teams with varying priorities and working styles to achieve project goals.
- Independently identifies opportunities for improvement of departmental work processes and contributes to a single large project or several small process improvement projects. Converts goals to tasks and coordinates activities to meet goals. Estimates and manages requirements to achieve defined objectives. Execute against defined objectives and keep management informed of progress and achieved project milestones.
- Apply project management principles and techniques to the coordination and completion of assigned goals and tasks. Prioritize tasks with effective use of time.
- Provide regular updates to CMC project team on progress of submission and after the content plan and timeline for the submission are set, ensure team is kept up to date if changes are made.
- Provide general training support, administration and guidance regarding project management practices and systems.
- Establish and maintain strong network within department and external stakeholders. Interacts with all levels of employees in support of project coordination.
- Assesses progress against plans, processes, and practices to determine effectiveness and recommend areas for process improvement to Manager/Director within the Dossier Management group.
- Bachelors with 12, Masters with 10, or PhD with 4 years of CMC functional experience including late-stage development experience.
- Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation, etc.) in order to assist CMC project teams in the planning, preparation, review and approval of submission documents.
- Create and maintain project management tools / templates in order facilitate the submission process.
- Contribute to cross-functional discussions around submission-related risk mitigation strategies.
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