Associate Director, Scientific Research, Medical Compliance Operations

Job Description

Hybrid. 3x days per week onsite in Lake County, IL.

This role is responsible for driving vision, strategic oversight, and operational execution for AbbVie Global Medical Compliance Operations in support of AbbVie Medical Affairs (e.

g., Global Medical Affairs and Health Economics and Outcomes Research, US Medical Affairs, Global Aesthetics Medical Affairs) reporting to the Director, Scientific Research, Medical Compliance.

Pursues continuous improvement and full alignment / connectedness to meet evolving business needs with research standards, processes, procedures, and training requirements through innovation and collaborative partnerships.

Demonstrates excellence in people leadership and development and working in a matrixed environment.

Major Responsibilities :

Strategic oversight of compliance, standards, and procedural documents (e.g., Policies, Processes, Standard Operating Procedures, Work Instructions, Forms, Guidance documents) related to evidence generation activities (e.

g., AbbVie-sponsored non-interventional studies, investigator-initiated Studies, collaborative research, exploratory data analysis, external data collection support) across Medical Affairs (MA)

• Provides tactical direction and oversight for research related audits which impact MA, including business representation, accurate and timely responses to queries, and remediation actions
• Adept knowledge of major industry regulations and guidelines, which apply to scientific research processes and procedures, and ensure applicable MA research-related policies and procedures properly reflect the regulation and guidance
• Continuously challenges current processes within AbbVie Global Medical Compliance Operations (MCO) to identify and improve performance, detect synergies, and optimize resources
• Establishes compliance risk assessments, trend analysis, and recommendations for compliance business activities, including compliance monitoring of evidence generation study activities, remediations related to relevant data sources, and reporting metrics on compliance performance to mitigate business performance risks
• Accountable for developing change management strategies and navigating change plans effectively and efficiently related to new and revised MA scientific research policies and procedures
• Develops, maintains, and delivers supplemental training materials and communications to relevant MA teams to enhance understanding of minimum standards of requirements
• May have a direct report(s) and may manage matrix teams
• Operates within MCO approved budget

Qualifications

• Bachelor's degree (or ex-US equivalent) with relevant experience required; advanced degree preferred
• 7+ years pharmaceutical, clinical research, or related industry experience; experience working with Medical Affairs functions is preferred
• Proven track record in process improvement initiatives utilizing change management techniques
• Demonstrated understanding of business processes and opportunities for partnership, as well as proven track record of effectiveness in working in a global organization
• Ability to navigate relationships with senior management as well as develop and deliver strategic presentations for such audiences
• Excellent communication skills, both verbal and written
• Demonstrated experience with leading people, coaching and mentoring
• Able to embrace change and lead implementation of new initiatives
• Preferred : Experience with both global and regional teams in the pharmaceutical industry. Demonstration of leading a global team Project Management, Change Management, or Process Improvement experience desirable

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.

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