Be an early applicantLess than 25 applicants

Company

Original Job Post

AbbVie · 5 days ago

Project Manager Stability Optimization

North Chicago, IL

Full-time

Onsite

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

Insider Connection @AbbVie

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Understand the current state of ongoing stability studies, compliance with ICH Q1D, and cost structure of the stability program.

Design the future state to reduce test points and presentations per product on stability through a matrix approach.

Collaborate with a cross-functional team to identify the optimum approach for product matrix and timepoints, draft technical memos, and prepare regulatory submissions.

Apply project management principles to develop a robust project plan, monitor progress, manage stakeholders, and provide updates to QA executive management.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Pharmaceutical industry experienceCGxPs knowledgeRegulatory affairsGlobal regulatory requirementsStability studiesProject managementPMP certificationProblem-solvingCommunicationNegotiationInfluencingIndependenceDecision-makingAnticipationCollaborationFirst-hand experience

Required

BS/BA degree in Science/Engineering/Business Management, or other related field of study

>5 years of experience in the pharmaceutical industry, solid knowledge and understanding of cGxPs; first-hand experience in Regulatory Affairs preferred

In-depth knowledge of global regulatory requirements for stability studies

Project Management experience, PMP certification preferred

Excellent verbal and written communication skills, effective facilitation and collaboration with a cross-functional team

Excellent negotiation and influencing skills

High level of competence, confidence, and credibility for interaction with senior management

Demonstrate high level of independence, decision making, anticipate program scope and deliverable changes, and effectively communicate issues with management

Preferred

First-hand experience in Regulatory Affairs

Benefits

Paid time off (vacation, holidays, sick)

Medical/dental/vision insurance

401(k)

Short-term incentive programs

Company

AbbVie

Glassdoor

3.9

AbbVie is a pharmaceutical company that discovers, develops, and markets medicines.

Founded in 2013

North Chicago, Illinois, USA

10,001+ employees

http://www.abbvie.com

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (155)

2022 (299)

2021 (194)

2020 (197)