Associate Scientist, Submissions Coordinator

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Qualifications :

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.

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 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 Companyssole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

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.

Qualifications :

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.

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 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.

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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Key Skills

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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