Senior Manager, CMC Dossier Program Management

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 projec