About this role
Proficiently manage the nonclinical portion of regulatory submissions involving multiple cross-functional subject matter experts. With input from the submission teams and project representatives, this individual establishes and maintains the nonclinical (Module 4) submission content planner, associated documents and timelines in support of development, marketing, and post-marketing regulatory authority applications.
Responsibilities
Oversee nonclinical submission content, ensuring the timely delivery of high-quality dossier components that align with technical specifications outlined by regulatory authorities. These components should facilitate easy navigation and review by regulatory agencies. Serve as a liaison with scientific Subject Matter Experts (SMEs), conveying established submission processes and standards.Coordinate and manage multiple interrelated activities concurrently for submission projects or various reports. Proactively anticipate obstacles and collaborate with the team to formulate solutions. Facilitate the creation or procurement of submission content deliverables such as summary documents, reports, and literature references.Conduct thorough quality assessments of published output, ensuring alignment with regulatory standards and health authority guidance. Verify content, including Study Tagging Files and SEND components (where applicable), bookmarks, hyperlinks and tables of content.Contribute to the development of optimal business processes and standards within the department, ensuring robust stakeholder support to achieve high quality submissions. Play a role in crafting and implementing internal standards for submission documents.Position accountability/scope:Regularly engage with the manager to discuss project priorities, timelines, progress and identified challenges.Manage projects with oversight as necessary.Provide training and cross-train with other team members to offer additional support as required. Bachelor’s Degree, or equivalent education.Theoretical and practical knowledge to carry out job functions.Preferred:
Experience supporting nonclinical research and development in the pharmaceutical industry preferred.Experience with GLP or related regulatory environments preferred. 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 thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographiclocation, 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 ofany bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company'ssole 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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