Manager, CMC Dossier Strategy and Leadership

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

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 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, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.
• This job is eligible to participate in 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 employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

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 AbbVies 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, visithttps://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