Senior Manager CMC Dossier Strategy and Leadership

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

Job Description

Purpose:

This position ensures that global regulatory CMC dossiers for clinical and marketing applications are created and aligned with current AbbVie’s CMC best practices. The role works with CMC teams during development of various projects and influences generation of adequate data packages suitable for regulatory submissions. The role collaborates to and authors CTDs to communicate a single, integrated strategy to health authorities, facilitates timely creation of regulatory CMC query responses and CMC briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content.

Responsibilities:

•Embedded in the CMC teams throughout project developments to collaborate on control strategy development and planning of suitable data packages that will support the strategies, provides real-time input on document preparation to ensure a submission-ready data set is generated.

•Actively contributes and/or leads team discussions on CMC topics, actively participates in discussions to develop adequate control strategy and regulatory strategy (story-boarding) as part of the CMC teams.

•Primary author of CMC sections for INDs/IMPDs and BLAs/MAAs to ensure a single, consistent story is communicated to health authorities, reviews CMC submission documents to ensure content alignment across the submission.

•Ensures timely delivery of CMC dossiers to meet regulatory submission timelines, authors regulatory CMC query responses and CMC information for briefing books.

•Attends meetings of interactions with agencies on CMC topics as required, serves as an internal SME for technical topics across the portfolio (e.g., mutagenic impurities, gross content control, etc).

•Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement processes.

•Establishes and maintains strong network within department and external stakeholders, utilizes established organizational network to identify opportunities and synergies consistent with project and/or department strategy. Actively mediates team discussions, and facilitates establishment of high performing teams.

Qualifications

Required:

Bachelor with 10, Master with 8, or PhD with 5 years of CMC functional experience including late-stage development experience

Preferred: 

Prior experience in a relevant CMC function (e.g., analytical, formulation, process, device/combination product development, etc) translating experimental work into at-scale drug substance or drug product manufacturing.

Technical writing experience communicating experimental development work, preferably including though contributions to INDs or marketing applications.

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. ​

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. 

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