Manager, Monograph Donorship Program
Manager, Monograph Donorship Program
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose
The Manager will be responsible for driving activities related to the planning and execution of AbbVies 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 crossfunctionally 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 :
- Bachelors 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 sites 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 crossfunctional team.
- Proficient organization planning and project management skills.
- High level of competence confidence and credibility for interaction with senior and executive management.
- Indepth 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 :
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 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
