Manager, CMC Dossier Strategy and Leadership
Manager, CMC Dossier Strategy and Leadership
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
This position participates in global regulatory dossier preparation activities by gathering information from internal and external (e.g. third parties) partners and authoring elements of the global dossier. The role prepares technical reports and data-rich sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of early-phase CMC control strategies. Implement well-defined efficient processes for preparation of these CMC documents.
Responsibilities:
- Authors data-rich sections of INDs MAAs and regional requirement documents
- Gathers source information from internal and external partners required to support dossier authoring activities.
- Authors technical reports (IPS DevChange etc.) to be used as source documents for dossier activities.
- Authors data-rich sections of INDs and MAAs based on current best-practices.
- Authors narrative-rich sections of early-phase INDs.
- Embedded in the early-phase CMC team of low/moderate complexity programs to collaborate on control strategy development and the planning of the data packages that will support the strategies
- Participates in quality checks to ensure the accuracy of dossier content and consults SMEs as needed.
- Independently prepares early development INDs.
- Contributes to developing automation tools to enhance authoring efficiency
- Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement projects.
- Establish and maintain strong network within department and external stakeholders. Utilize established organizational network to identify opportunities gaps and synergies consistent to improve efficiency within role.
Qualifications :
- Bachelors with 8 Masters with 6 or PhD with 3 years of CMC functional experience.
- Prior experience in a relevant laboratory-based CMC function (chemistry analytical formulation 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.
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 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
Employment Type
Full-time
