Senior Manager CMC Dossier Strategy and Leadership
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Purpose:
This position ensures that global regulatory CMC dossiers for clinical and marketing applications are created and aligned with current AbbVies 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Marketing
- Data Visualization
- Tableau
- Customer Segmentation
- Microsoft Powerpoint
- Investment Banking
- Strategic Planning
- Financial Modeling
- Customer relationship management
- Management Consulting
- Google Suite
- Analytics
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
