Job description
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Tasked with implementing the vision and process framework of the CDMSO team by advising employees and teams on executing continuous improvement initiatives. This role coordinates highly effective teams by developing staff and delegating appropriate work assignments and priorities to execute continuous improvement initiatives. Responsibilities include planning and allocating functional resources, developing and managing high-performing teams, and assigning tasks across one or more therapeutic areas to achieve objectives while ensuring compliance with GCP and AbbVie SOPs.
- Prioritizes workloads and maintains real-time inspection readiness of Master Files and plans and allocates resources effectively across assigned therapeutic areas.
- Leads departmental and cross-functional initiatives within the broader Development Organization.
- Maintains compliance with GCP, AbbVie SOPs, and functional area processes for both staff and clinical documentation in assigned therapeutic areas.
- Acts as an advisor on clinical documentation initiatives and serves as the Business Process Owner for Document Management.
- Contributes to setting CDMSO strategy, goals, and initiatives as part of the CDMSO leadership team.
- Coordinates cross-functional initiatives and ad hoc projects.
- Coaches and mentors team members for professional growth within team and the broader organization.
- Analyzes metrics, recommends actions, and collaborates with the systems team to identify improvement areas.
- Promotes a culture of innovation, collaboration, and professional development.
- Meets with Program Leads and stakeholders to update on TMF health, escalate issues, and discuss milestone and regulatory filing dates.
- Has direct reports
*This is a US Remote position
Qualifications
- Bachelor’s degree or international equivalent is preferred. Degree in life sciences or business preferred. With at least 8 years clinical document management or clinical research industry-related including Supervisory/ leadership. At least 3 years People Management experience. If no BS, 12 years professional clinical research relevant work experience.
- Proven communication, organizational, project management and leadership skills.
- Skilled at problem solving and prioritization at operational and tactical levels.
- Ability to analyze organizational needs and assist in the design, implementation, and maintenance of flexible work teams, capable of meeting changing business and regulatory requirements.
- Ability to lead operational strategy and deliverables for the business. Ability to lead employees through organizational changes.
- Proficient in leading risk/impact assessment and change management within the organization
- Effective, strong leadership competencies with broad business orientation.
- Ability to drive strategic and operational goals through project advisement, prioritization and employee development.
- Ability to lead employees through organizational, process and procedural changes
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 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.
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
