Project Manager, Disclosure

About AbbVie
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.

• Collects and analyzes global disclosure requirements, assesses the impact of actual and proposed changes for new or changed US and International regulations. Implements and maintains database with key country/region specific requirements and expectations that optimize process and communication.
• Determines AbbVie studies required to be registered and results disclosed for compounds across pharmaceutical development and therapeutic areas. Implements processes/ procedures to ensure accuracy, consistency, and alignment of clinical data/information made public, utilizing an understanding of global external databases and other public sources of clinical and scientific information.
• Monitor clinical trial disclosure compliance through clinical trial registration and results disclosure processes and oversight to maintain compliance with state, federal, international, and PhRMA registration and disclosure requirements.
• Develops and maintains strong relationships globally and cross-functionally. Collaborates with key functional team members (Regulatory, QA, Safety, Legal, PPG, IMD, Clinical, Statistics, Affiliates) for timely and efficient handoffs to ensure requirements and major milestones are achieved.
• Manages requests from external Researchers for access to AbbVie’s clinical data/information under PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.
• Assists SMEs with identifying Commercially Confidential Information (CCI) and composing defendable justifications for the identified information. This includes searching global external databases and other public sources of clinical and scientific information to confirm the information has not been publically disclosed and educating SMEs on what constitutes CCI.
• Manages the review/preparation of documents redacted for CCI and protected personal data (PPD) for public disclosure to meet various business needs. For example, the review of EPARs or AusPARs, or proposed and final Redacted Document packages for submission to the EMA in alignment with EMA Policy 0070 guidance.
• Responsible for contributing to a culture of process improvement, performance measures, project prioritization, and developing successful solutions. Participates in global cross-functional disclosure teams and initiatives. Recommends, leads, and implements tactical process improvements.
• Identifies and anticipates issues and develops contingencies.

Qualifications

• Bachelor’s degree is required. Advanced degree is desirable.
• 3-5 years relevant industry experience in quality, regulatory, compliance, clinical research, or drug development. Clinical research experience preferred.
• Experience in working with collaborative, cross-functional teams, including project management experiences.
• Demonstrated success in managing broad scope/global projects involving cross-functional teamwork.
• Excellent communication (written and verbal), organization, planning, execution, and team leadership skills are required.
• Relationship management, communication ability, influencing skills required.
• Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.