Associate Project Manager
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Associate Project Manager, TrackWise Management is responsible for successful executions of all global updates and configuration changes and site support/administration for CPR TrackWise for Product Surveillance. Coordinates with Product Surveillance teams and cross departmental Allergan teams to ensure CPR TrackWise system complies with departmental procedures and industry governmental regulations. Supervise personnel carrying out TrackWise administration activities in accordance with the organization's policies and applicable laws.
Key Duties and Responsibilities:
- Supervise and coordinate all updates and configuration changes for TrackWise including reviewing and gathering requirements for system changes, mapping new products, developing and running validation test scripts, and updating documentation. Ability to analyze system change requests and ensure compliance under MDR regulation, 21 CFR 820, CMDR SOR/98-282, ISO 9001, and ISO 13485:2016.
- Support all inquiries relating to CPR Product Mapping including CPR system data discrepancies, new product mapping, current product re-mapping, and product information research.
- Review all Business CPR Change Requests to determine if changes should be updated to CPR. If changes are not needed, review with Requester for reasons. If the changes are needed, review the request to establish high-level requirements to be submitted to RDQ IT.
- Work with the RDQ IT Developers to determine the detailed requirements, update current requirements to determining testing procedures, and help prevent potential issues that may come about due to the changes.
- Review changes in CPR Development, ensuring the changes are aligned with the requirements and identify system bugs.
- For system validation, developed test scripts to formally validate changes applied to the system.
- Process Change Request Forms, system risk assessments, requirements (User, functional, design specifications), Validation plans, Users acceptance or operational qualifications and summary report documents development/update, review, and approvals.
- Run required test scripts for changes in the validation environment meeting user acceptance or operational qualifications.
- Review Product Surveillance documentation for potential updates as a result of system changes that impact processing.
- Perform administrative functions in the safety database. Ensure appropriate code lists, letters, and user profiles are established and maintained.
- Train and assist Management, Quality Engineers, Representatives and Contract Employees.
- Provide system update notifications, create training material, and ensure user training scheduling and training.
- Assess and define department training needs. Confirm all training needs are met, and process training records
- Provide generalized company, departmental and product knowledge as required.
- Respond to verbal and written requests from internal and external customers as needed.
- Generate “talking points” and other documents that effectively communicate corporate policies and directives.
- Provide Daily CPR Support to users having issues, questions or inquiries
- Review and aid in any CAPA/Deviation root cause analysis and investigation.
- Provide general support to PS SharePoint questions, issues, site updates/creations, and access.
- Monitor department process and workflow for opportunities for improvement and optimization.
- Establish performance metrics to ensure case-files are completed timely and service levels are met. Monitor quality of employee customer calls, ensuring that the highest level of service is given.
- Monitor work flow to ensure quantity and quality are consistently met. Continually initiate plans to maximize use of resources, and/or take corrective action to resolve problems to accomplish department tasks and goals.
- Review administrative procedures and systems for improvements. Write or revise policies and procedures in accordance with FDA and Vigilance regulations, and ensure completion through the change control process.
- Conduct supervisory activities such as interviewing/hiring new employees, processing time records and vacation/absence requests, producing and administering performance evaluations and any employee disciplinary actions as required.
- Ensure that the area and equipment are operating safely and notify responsible person to make changes in order to maintain a safe area. Monitor safety procedures for compliance with company procedures.
Education and Experience
- Bachelor’s degree and three to five years related experience and/or training required with at least two years in a supervisory capacity or equivalent combination of education and experience preffered.
- Previous experience in customer service or user interface in a medical environment desired.
Essential Skills and Abilities
- Ability to communicate and collaborate with other departments such as the Information Technology, Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, and Marketing departments to ensure corporate goals and strategies are met. This includes other facilities such as Costa Rica, Marlow, UK, and Pringy, France.
- Set a good example for all employees in performance, attendance, dress, and professionalism.
- Ability to provide accurate and complete information in a prompt manner.
- Ability to initiate or suggest plans to motivate workers to achieve work goals.
- Utilize matrix management within department as needed.
- Ability to read, analyze, and interpret complex documents.
- Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
- Ability to coordinate and synchronize multiple projects.
- Ability to be flexible in changing daily workload priorities as directed.
- Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities.
- Ability to handle restricted, confidential, private, or personal information in accordance with departmental policies, HIPAA, and related international standards.
- Ability to guide and delegate to subordinates. Ability to analyze training needs. Ability to administer employee discipline.
- Ability to travel to meetings and professional seminars. Ability to drive a car; possess a valid and current driver’s license.
“The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per the requirements of 21 CFR 820, ISO 13485 and ISO 14971. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.”
Significant Work Activities
Yes, 15 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.