Senior Manager, CMC Dossier Management

AbbVie Inc.; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Inc. in North Chicago is seeking a Program Manager, CMC Dossier Management to lead and oversee CMC regulatory deliverables, including INDs/IMPDs and marketing applications, using standardized project management tools.

You will map source documents, maintain rosters and timelines, coordinate cross-functional teams, and drive process improvements while ensuring on-time submissions and accurate content plans.

Qualifications

• Bachelor's degree with 12 years or Master's with 10 years or PhD with 4 years in CMC functional experience.
• Prior experience in a laboratory-based CMC function to support submission planning.
• Create and maintain project management tools/templates for submissions.
• Contribute to cross-functional discussions on submission-risk mitigation.

Responsibilities

• Monitor progress of regulatory submissions against timelines.
• Map and track source information supporting submission sections.
• Maintain rosters and timelines for multiple projects.
• Provide dossier support including content plans and source documents.
• Collaborate with CMC RA and leads; assist with resource estimates.
• Identify opportunities to improve departmental processes and projects.
• Coordinate activities to meet defined objectives and milestones.
• Provide updates to the team on submission progress and changes.

Skills

CMC project management

Regulatory submissions

Cross-functional coordination

Process improvement

Education

Bachelor's or higher in relevant field

Master's degree preferred

PhD with experience considered

Job 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 . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Program Manager, CMC Dossier Management

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.

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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law.

Compensation & Benefits

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.
• Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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.

US & Puerto Rico only.

US & Puerto Rico applicants seeking a reasonable accommodation.