CMC Dossier Management Lead – Senior Manager

AbbVie Inc.; Chicago (IL); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

AbbVie is seeking a Program Manager, CMC Dossier Management to help develop and oversee CMC regulatory submission plans (INDs/IMPDs and Marketing Applications). This role coordinates content plans, source document maps, and timelines using standardized PM tools, ensuring timely delivery and accuracy of submissions.

The candidate will work with CMC RA and functional area leads to monitor progress, manage risks, and provide updates.

Qualifications

• Bachelor's with 12, Masters with 10, or PhD with 4 years of CMC functional experience including late-stage development experience.
• Prior experience in a laboratory-based CMC function (chemistry, analytical, formulation, etc.) to assist CMC project teams in the planning, preparation, review and approval of submission documents.
• Create and maintain project management tools / templates to facilitate the submission process.
• Contribute to cross-functional discussions around submission-related risk mitigation strategies.

Responsabilités

• Provide dossier support to CMC projects team, including creation and maintenance of content plans, source document maps, rosters, and timelines.
• Coordinating diverse teams with varying priorities and working styles to achieve project goals.
• Identify opportunities for improvement of departmental work processes and contribute to large project(s) or multiple small process improvement projects.
• Apply project management principles and techniques to coordination and completion of assigned goals and tasks.
• Provide regular updates to CMC project team on progress of submission and timelines; keep team updated if changes occur.
• Provide general training support, administration and guidance regarding project management practices and systems.
• Establish and maintain strong network within department and external stakeholders; interact with all levels of employees.
• Assess progress against plans and recommend process improvements to Management within the Dossier Management group.

Connaissances

CMC project management

Cross-functional collaboration

Process improvement

Formation

Bachelor's/Master's/PhD with CMC experience

Outils

Project management tools/templates

Description du poste

AbbVie is seeking a Program Manager, CMC Dossier Management to help develop and oversee CMC regulatory submission plans (INDs/IMPDs and Marketing Applications). This role coordinates content plans, source document maps, and timelines using standardized PM tools, ensuring timely delivery and accuracy of submissions.

The candidate will work with CMC RA and functional area leads to monitor progress, manage risks, and provide updates.