Associate Scientist, Submissions Coordinator (ON-SITE) Full-time

Job Title

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.

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.

Qualifications

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.

Additional Information

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.

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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Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.