Senior Manager, CMC Dossier Management

BioSpace; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie seeks a Program Manager, CMC Dossier Management to develop and oversee CMC regulatory deliverables, including INDs/IMPDs and Marketing Applications. You will coordinate content plans, source document maps, rosters, and timelines using standardized PM tools to ensure on-time submissions.

Responsibilities include monitoring submission progress, maintaining rosters, supporting cross-functional teams with risk analysis, and driving process improvements.

Qualifications

• Bachelor's degree plus 12 years of CMC functional experience, Master’s 10 years, or PhD 4 years in late-stage development.
• Experience in a laboratory-based CMC function to assist teams with submission documents.
• Ability to create and maintain PM tools/templates to facilitate submissions.

Responsibilities

• Assist development and oversight of CMC regulatory deliverables (INDs/IMPDs, Marketing Applications).
• Create and maintain content plans, source document maps, rosters, and timelines.
• Monitor submission progress against timelines and manage risks with root-cause analyses.

Skills

Cross-functional collaboration

Project management tools/templates

Regulatory submission knowledge

CMC experience

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

PhD in a relevant field

Job description

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

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 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

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

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 - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html