Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The Director, CMC Dossier Management leads the development and oversight of Chemistry, Manufacturing, and Controls (CMC) strategic project plans and associated timelines 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 working with the CMC project team and external stakeholders to identify and track dossier sections required for a regulatory filing, mapping and tracking source information which support individual sections, maintaining accurate rosters, and generating timelines, and scenario planning.

Responsibilities:

• Independently provide advanced project management support to multiple complex (e.g. early-late stage, requiring a device, etc.) CMC project teams, including creation and maintenance of content plans, source document maps, rosters, and timelines.

• Leads Submission Working Group (SWG) meetings, including setting agenda topics, capturing action items, and driving discussions with CMC RA and CMC authors. Drives SWG team accountability to meet deliverables. Develops multiple project planning scenarios in collaboration with SWG team members; identifies, monitors, and analyzes business risks. Recognizes when corrective action and planning are necessary and conducts root cause analyses (escalating recommendations to SWG Team). Manage activities to ensure functions have the right tools, reports, and data for 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 manages large and small cross-functional process improvement projects. Spearheads the definition of departmental vision and strategy. Converts goals to tasks and coordinates activities to meet goals. Estimates and manages requirements to achieve defined objectives. Lead multiple process improvement teams through execution on defined objectives and keep management informed of progress and achieved project milestones.

• Apply sophisticated project management principles, including stakeholder engagement, risk management, and quality management, along with comprehensive techniques such as the Critical Path Method, Gantt charts, and Agile methodology, to coordinate and complete assigned goals and tasks in CMC project management. 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 information if changes are made.

• Apply advanced project management tools for metrics collection and conduct advanced analysis of project data. Develop guidelines and checklists. Utilize and implement tools to identify novel solutions for metrics collection, data analysis and process improvement.

• Serves as local expert for business procedures and recommends solutions to R&D (Development Sciences, Regulatory, etc). Develop and provide advanced training courses, presentations, and guidance to foster best practices. Establish and maintain strong network within department and external stakeholders. Utilize established organizational network to identify opportunities, gaps and synergies consistent with departmental strategy. Actively manages cross-functional and departmental team behaviors, mediates internal team disputes, and facilitates establishment of high performing teams. May manage junior staff and/or Program Managers within the department.

• Interacts with all levels of employees in support of project coordination. Effectively influences senior leaders regarding project initiatives and direction.

• Defines performance expectations and holds team accountable for progress against plans, processes, and practices to determine effectiveness and areas for process improvement.

Qualifications

This position will be required to sit on-site 3 days / week

• Bachelors with 18, Masters with 16, or PhD with 10 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.

• In collaboration with functional area, identify submission-related risks and develop 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 short-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. ​

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AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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

Salary: $172,000 - $326,500