Senior Manager, CMC Dossier Management

AbbVie Inc.; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

CMC project management

Cross-functional collaboration

Process improvement

Education

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

Tools

Project management tools/templates

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 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

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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

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