Manager, Submission Operations

Employer
AbbVie
Location
Lake County, IL, US
Posted
Mar 23, 2019
Ref
1902111
Required Education
Bachelors Degree
Position Type
Full time
The Manager Submission Operations is to combine knowledge of health authority regulations and the technical publishing processes and systems to product submissions to meet health authority requirements. Serves as an expert lead in monitoring and assessing the impact to the organization of changing regulations and guidance. Additionally, the individual may develop and supervise publishing professionals in support of product submissions. Provides leadership and guidance in communicating and evaluating existing agency regulations and guidance impacting submission processes and standards.

Key Responsibilities Include:
    Develops and/or updates processes, work instructions, and job aids for publishing processes as well as trains personnel accordingly.
    Evaluates the risks of division policies, processes, procedures on the publishing process.
    Monitors health authority and trade association guidance and specifications for impact on submission processes and standards.
    Develops contingency plans to ensure resource constraints or potential schedule delays are proactively resolved minimizing impact on submission schedules.
    Recruits, develops and manages Publishing professionals. Manages staff by providing direction and guidance to exempt and/or non-exempt personnel. Evaluates performance of and assists in career development planning for subordinates.
    Ensures adherence to standards for all submissions.
    Manages submission publishing activities, processes and standards with offsite vendor.
  • Ensures compliance to internal and external submission timelines and requirements for all submissions.
  • Makes decisions regarding work processes, operational plans, and schedules in order to achieve objectives established by senior management.
  • Responsible for providing reports, metrics and status regarding submission planning, volume and resource utilization.
  • Demonstrates team leadership skills and ability to influence. Builds and maintains positive relationships internally and externally.


    Required Education: Bachelor's Degree Preferred Education: Advanced Degree a plus Required Experience: 7 years pharmaceutical or industry related experience Experience working in a complex and matrix environment. Strong communication skills both oral and written Preferred Experience: 1-2 years in Submission Operations, Registration Management, or cross functional IT project management Experience in Regulatory Operations, including regulatory submission project management, submission publishing and/or registration management is preferred. Proven leadership skills and presence NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.