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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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This role is responsible for supporting day to day evidence generation activities in Medical Compliance Operations (MCO) reporting to the Director. The primary function of this position is to perform activities such as implementing controls for Medical Affairs + Health Impact (MHI) evidence generation, providing oversight of related research standards, processes, procedures, and training requirements.
Responsibilities:
Gain thorough knowledge of research related standard operating procedures (SOP) applicable to MHI research and assess and escalate changes that may impact MHI.
Support research related audits (corporate/system/inspection) which impact MHI. Performing activities such as ensuring business representation (MHI) to ensure access to documentation, accurate timely responses to queries and remediation actions.
Conduct routine monitoring of research and support any required reporting. In addition, support enhancements to the monitoring process.
Ensure familiarity with any related document system repository.
Monitor MHI managed systems and available tools designed to support evidence generation activities (AbbVie sponsored studies, investigator-initiated studies (IIS), external collaborative studies, exploratory data analysis, external collaborative registry/consortium, registry/database design sponsorship, database analysis sponsorship or grant, data set/analysis purchase), for accuracy and provide updates as needed to applicable procedures and/or training.
Track ongoing requests for modification to the MHI research related procedures (e.g., IIS SOP and work instructions) until routine update. Manage relevant stakeholder list and support the collaborative review process to completion.
Ensure research related compliance issue tracking such as MHI issues, planned deviations and non-conformities are properly documented. Oversee records in the exception reporting system and assist area/affiliate to gather required details for the system. In addition, assist in any process improvement to exception tracking in MCO.
Assess regulations for potential impact on evidence generation activities.
Bachelor's degree with relevant experience required; advanced degree preferred
5 years pharmaceutical or related industry experience
Demonstrated abilities in relationship building and partnership capacity required. Builds strong relationships with peers and cross functionally with partners to enable higher performance.
Excellent leadership, self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
Able to operate effectively within a matrixed environment, embrace change, and lead implementation of new initiatives; can decide and act without having the total picture and can comfortably handle risk and uncertainty.
Excellent business communication skills with aptitude for summarization, as well as detail orientation.
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.
This job is eligible to participate in our long-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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://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
