Address
Form of workAbbVie'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. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
Purpose
The Change Control Author is the primary point of contact to provide Change Control execution for drugs, biologics, and medical devices. This role works across multiple functions to bring the appropriate individuals together to build robust change strategies that will be documented in the Change Management IT system (TrackWise).
Responsibilities
- Serve as Change Contropl Authorfor Local Change Plans or Global Change Plans for mature products within a franchise
- Work with Requestors of change to ensure Change Proposals are ready for review
- Facilitate Cross Functional Team meetings with individuals across multiple geographies
- Document Change Plans in SolTRAQs Change Management system
- Facilitate Change Review Board meetings to review and approve Change Plans
- Progress Change Plans through the SolTRAQs workflow
- Monitor open Change Plans/Tasks and provide visibility to Requestors and the Change Review Boards
- Accountable for the compliance of the Change Plan documentation to the applicable processes and procedures
Qualifications
- High School degree with 5 years professional experience or College degree with 3 years professional experience required
- Minimum 3 years in the Medical Device or Pharma industry required
- General knowledge regarding FDA regulations, ISO standards and ICH guidelines required
- TrackWise experience is preferred
- Technical writing experience is preferred
- Project Management experience is preferred
- Support of marketed products experience is preferred
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 ingood faith it will pay for this role at the time of this postingbased on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more orless 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/visioninsurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
