Manager, Monograph Donorship Program - AbbVie : Job Details

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.

Purpose: The Manager will be responsible for driving activities related to the planning and execution of AbbVie's Monograph Donorship Program.

Responsibilities:

• Lead the creation and alignment of the Monograph Donorship Long Range Plan.
• Manage the execution of the Monograph Donorship Long Range Plan, including the creation of monographs.
• Work cross-functionally to collate the required information for monograph creation from relevant functions.
• Develop monograph drafts.
• Serve as the primary point of contact for Monograph Donorship, both internally and externally (towards applicable pharmacopoeia).
• Lead cross functional team review and approval for monograph submission (e.g. operations leadership, legal, etc...).
• Lead quarterly Monograph Donorship Long Range Plan review meetings and present program status update to stakeholders and executive leadership.
• Establish and maintain the necessary process and work instruction procedures for the program.
• Manage the assessment and implementation of compendial changes according to official timelines.

Qualifications:

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 6 years in quality assurance and/or quality system oversight. 5+ years of experience with working and/or developing analytical methods in QC, S&T or R&D labs.
• Experience working in a manufacturing site preferred.
• Experienced in the use of standard software applications including Office 365.
• Strong interpersonal & communication skills.
• Excellent verbal and written communication skills, effective facilitation and collaboration with a cross-functional team.
• Proficient organization, planning, and project management skills.
• High level of competence, confidence, and credibility for interaction with senior and executive management.
• In-depth knowledge and experience of compendia preferred.
• Demonstrate high level of independence, decision making, anticipate program scope and deliverable changes, and effectively communicate issues with management.

Additional Information:

• 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

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.