Senior Manager, CMC Dossier Management

AbbVie; North Chicago (IL); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie Inc. in the United States seeks a Program Manager, CMC Dossier Management to oversee regulatory submission content plans, source document mapping, and timelines for INDs/NDAs. You will coordinate with CMC RA and functional area leads to monitor milestones and manage risks.

The role requires strong project management skills, experience in CMC late-stage development, and the ability to guide cross-functional teams through complex dossiers and audits, ensuring accuracy and timely delivery.

Qualifications

• Bachelors with 12, Masters with 10, or PhD with 4 years of CMC functional experience.
• Prior experience in a laboratory-based CMC function to assist project teams with submissions.
• Create and maintain project management tools and templates for submissions.
• Contribute to cross-functional discussions on submission risk mitigation.

Responsibilities

• Provide dossier support including content plans, source maps, rosters, and timelines.
• Coordinate with CMC RA and leads to monitor milestones and risks.
• Identify process improvements and drive action on defined objectives.
• Apply PM principles to coordinate goals and track progress.
• Provide updates to the team on submission progress and changes.
• Assist with training and governance of project management practices.
• Build network with internal and external stakeholders across the department.

Skills

CMC project management

Regulatory submissions

Cross-functional coordination

Root cause analysis

Risk mitigation

Project scheduling

Education

Bachelor's degree in a relevant field

Master's degree in a related field

PhD in a related field

Job description

• Compensation: USD 124,500 - USD 236,500 - yearly

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com .

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 submissioncontent 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.

Qualifications

• 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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.