About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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.

• Bachelors 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 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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability ofanybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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