Full Job Description
A sustainable process development and continuous improvement strategy is an integral part of a Quality Management System in GCP governing Research & Development (R&D). The Compliance Learning Change Management (CLCM) organization resides within Clinical Development Operations to sustain an interconnected process and operations ecosystem by seamlessly empowering teams to connect ideas and create meaningful impact. The Associate Director, Strategic Change Enablement serves as a primary interface between the client and the Compliance Learning Change Management (CLCM) function. Strategic partner with key stakeholders in their areas of focus throughout full lifecycle of strategic initiatives and delivery of solutions - from defining business needs, project planning, development, deployment, change management, and end user adoption - that supports operational excellence in clinical trial execution. Design clinical research processes and ensure alignment with cross-functional stakeholders.
Responsibilities
347 Responsible for understanding AbbVie's Quality System and Regulations related to GXP activities and the Business Process Framework and is able to translate to stakeholders347
347 Thorough understanding of Clinical Trial Management Systems and other associated systems for areas of focus347
347 Understand the remit of CLCM in order to leverage their expertise in support of initiative execution347
347 Design clinical research processes (e.g. through process mapping and workshops), ensuring alignment with cross-functional stakeholders, and partnering on strategy for implementation, and maintain supporting systems and documentation347
347 For functions supporting clinical research, facilitate design of organizational roles and responsibilities, and integrations into AbbVie's Quality System347
347 Develop and deliver on initiative change management strategy, including stakeholder and impact assessments, initiative communications, content development and hosting sessions347
347 Manage systems and global program(s) that enable delivery of process & change management347
347 Strategic assessment of metrics and measures for their areas of focus347
Qualifications
347 BS or BA required; advanced degree preferred347
347 8+ years of experience in pharmaceutical, healthcare or regulated industry preferred.347
347 Experience in a leadership role with strong management skills in a complex matrix environment, preferably in the healthcare industry.347
347 Demonstration of successful execution of compliance and training strategy in a fast-paced environment managing multiple priorities effectively using innovative and creative solutions.347
347 Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).347
347 Demonstration of successful coaching/ mentoring, people management and communication skills in a matrix environment.347
347 Effective leadership skills with a proven ability to foster global team productivity and cohesiveness.347
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
347 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 thisposting 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.347
347 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.347
347 This job is eligible to participate in our long-term incentive programs.347
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 anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.