Associate Director, Benefit-Risk Management (BRM) Project Management

Lake County, IL, US
Aug 26, 2018
Required Education
Bachelors Degree
Position Type
Full time
This position reports into the Office of the Product Safety Team (OOPST) in the Pharmacovigilance and Patient Safety (PPS) organization. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide.

This position provides strategic project management leadership for the Benefit-Risk Management (BRM) Group within the Safety Science organization. The BRM group is responsible for promoting excellence in structured benefit-risk (B/R) assessment and patient-centered risk management (RM) throughout the product lifecycle.

Responsibilities :
  • In partnership with Head, BRM and BRM Leads, shape the BRM Group strategic priorities and drive implementation
  • Drive timely development of key BRM deliverables by planning and facilitating productive working sessions to create deliverables; share perspectives; push the thinking to create robust deliverables, suggest improvements and connect the dots.
  • In partnership with the Head, BRM and BRM Leads, manage multiple complex BRM initiatives. This includes meeting planning and facilitation, meeting minute documentation and post-meeting/general team management activities. Increase meeting productivity and advance decision-making effectively through the application of strong skillsets in strategic thinking, influence, leadership, relationship building, proactiveness, curiosity and active engagement. Mentor, coach and train less experienced PST PMs .
  • Work with affiliates and Office of QPPV to implement risk minimization tools / materials globally.
  • Manage resource forecasting and planning for BRM deliverables to support new product submissions and on-market product lifecycle management. Shape BRM educational strategy and drive execution.
  • Support the Head, BRM and BRM Leads in strengthening internal partnership/influence and establish role as the company leader of structured B/R and RM activities across the AbbVie portfolio. Identify new opportunities for the Head, BRM and BRM Leads to build relationships (e.g. with Business Process Office and PV Alliance Management/Legal) and present thought leadership internally.
  • Support the Head, BRM and BRM Leads in strengthening external engagement/presence by providing recommendations on channels for expanding external engagement including topic ideas for publications, conferences to present at, key industry relationships to develop, etc. Provide significant contributions to the creation of content for external engagement activities.
  • Proactively promote best practice and knowledge sharing among BRM Leads and manage the BRM knowledge management site. Share project management best practices with other PM teams across OOPST and seek to learn and adopt their best practices. Act as a PM Champion within the OOPST organization and mentor other PMs to adopt best practices. Provide coaching and training on process excellence tools, skills, mindset, ways of working and behavior. Champion continuous improvement opportunities for the BRM group to establish an agile and high performing BRM group.
  • Support inspection/audit readiness activities and CAPAs/commitments.
  • Support BRM activities for product launches
  • Ensure BRM deliverable timeliness and quality levels are met through addressing alignment, consistency and data integrity.

  • Bachelor's degree in a healthcare discipline (i.e.: Life Science, Pharmacy, nursing or healthcare profession, or biomedical disciplines), Masters or advanced degree is desirable.
  • At least 7 years' hands-on project management experience in leading cross-functional projects within a global company. Hands-on experience applying project management tools and templates.
  • At least 7 years' experience working in the healthcare industry and a strong understanding of the drug development process.
  • Experience in one of the following areas: clinical operations management, clinical study management, drug development, risk management, pharmacovigilance and/or drug safety operations
  • Understanding of the connections between regulations and science for drug development.
  • Comprehensive knowledge of the drug development process which includes: conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, Regulatory requirements for submission, product launch and post marketing support.
  • Strong leadership presence. Experience in working directly with and influencing senior management including functional heads.
  • Established track record leading cross-functional projects within a global company. Demonstrated effectiveness in working in multidisciplinary, matrix team situation and demonstrated ability to manage change.
  • Proven experience with external partner relationship management.
  • Proven leadership and communication skills that minimally include: Effective and timely communication of project objectives, issues/risks as well as other project information required to keep the team and management informed. Decisive yet collaborative leadership style.
  • Ability to adapt in a quickly changing environment, ability to engage team members across functions to facilitate information sharing in order to maintain a continuous flow of information; capability to clearly present, influence and logically justify positions/proposals; sound judgment; manages conflict and negotiation constructively; ability to develop build strong working relationships to enable high performing teams.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled