Associate Director, Medical Compliance Operations - Material Review

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Reporting to the Director, Material Compliance Operations- Material Review, the Associate Director of Global Material Review Compliance is accountable for implementation of processes, standards and compliance monitoring and supplemental medical compliance training supporting the scientific development and review of medical content of pharmaceutical promotional and non-promotional materials for marketed and investigational products/devices.  This position plays a crucial role in ensuring presentations of medical, scientific information, and documentation meet various standards for pharmaceutical promotion and scientific exchange.  This role is responsible for fostering positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Headquarters, Affiliates and US commercial organizations, HEOR, , regulatory affairs, legal, public affairs, and OEC.

Responsibilities:

• Implement processes, and tools to support material development and review compliance to support the ability of the organization to effectively execute strategic plans.  Fosters the vision and strategic direction for use within scientific material for the medical organization. This involves establishing clear processes, policies and procedures to support professionals dedicated to delivering accurate, high quality and compliant medical and commercial communications for AbbVie both Globally, and in the US. 
• Maintains processes and standards outlining requirements for the development, review and approval of scientific materials and compliant data source requirements for non-promotional materials for use with externally facing customers.   
• Participates in compliance risk assessments, trend analysis and recommendations for compliance business activities.
• Provides expert guidance on regulations and internal policies and their impact on promotional and non-promotional material review processes and procedures. Expertise stretches beyond dissemination and/or promotion of medical and drug/device information into regulatory impact, Global business requirements, enforcements, knowledge of industry trends and processes for global and US audiences.
• Responsible for the reporting of metrics and related compliance monitoring for data sources.
• Accountable for monitoring, reporting, and remediation related to relevant data sources for materials to determine compliance performance KPIs to mitigate business performance risks. 
• Develops, maintains, and delivers proactive supplemental training materials and communications to relevant Medical Affairs + Health Impact team members to enhance understanding of minimum standards of promotional and non-promotional requirements for approved data sources within materials. Assesses Global TA team needs related to compliant scientific materials.
• Remains current in AbbVie policies, Medical Affairs + Health Impact related regulations, and new regulations affecting Medical Affairs to enhance systems, processes, and procedures accurately to reflect current Global standards.

 

• Bachelor’s degree (or ex-US equivalent) with related health science background:  BSN, BS, PharmD.  Advanced degree or extensive experience in operations and/or performance (commercial/customer) excellence is preferred (PhD, RN, PharmD,) 
• 5-10 years’ experience in medical review required. 
• Ability to influence others without direct authority. 
• Excellent communication skills, both verbal and written
• Excellent leadership, analytical, project management, self-management, and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
• Previous experience in situations of conflict resolution, problem solving, or crisis management preferred.  Excellent interpersonal, communication (both oral and written), and relationship building skills.
• Key Stakeholders: Able to operate effectively within a matrixed environment.  Able to embrace change and lead implementation of new initiatives; can decide and act without having the total picture and can comfortably handle risk and uncertainty.

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 postingbased 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 paymore 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 Company's sole and absolute discretion unless and untilpaid 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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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