Senior Analyst, Regulatory Affairs Information Management
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
The Senior Analyst Regulatory Affairs Information Management is responsible for monitoring the activity in Cosmos (the Regulatory Information Management system) for assigned portfolio products and ensuring the completeness and accuracy of RIM data in the Cosmos system. Works with submission teams and provides appropriate guidance for managing the lifecycle of product submissions applications and authorizations in Cosmos as described in functional area procedures.
Responsibilities:
- Determines system properties appropriate for the classification type/submission type of object desired by the business in Cosmos
- Elevates non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations.
- Demonstrates ability to apply knowledge in a regulated environment.
- Responsible (with managers oversight as needed) for educating internal customers on Regulatory information issues including commercial public affairs clinical development legal quality and others who contribute to RIM.
- Functions independently in decision making for routine issues.
- In conjunction with manager reviews complex issues and problem resolution successes and setbacks to assist in future problem-solving applications/options.
- Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems.
- Prepares routine communications for functional area and senior leadership as requested.
- Executes business processes for activity type and product information management within Cosmos.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications :
- Required Education: Bachelors degree in (pharmacy biology chemistry medical technology pharmacology) related life sciences
- Required Experience: 4 years in regulatory affairs R&D or related area.
- Experience working in a complex global matrix environment with diverse team members. Good communication both oral and written
- Preferred Experience: Experience working with electronic regulatory submissions and data standards prior experience in a regulatory affairs strategy role 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 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.
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 Companys sole 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:
No
Employment Type :
Full-time
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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
