Location: Full time remote in the US (There may be some travel to San Diego, CA in the later half of 2021 and early 2022) Shift hours: 8am – 5pm Must be / Holder on W2 Job Description:
This position will serve as a Regulatory Project Manager on one or more of Intercept's Program Teams, cross-functional teams responsible for implementing the company's strategy and overseeing global development activities for obeticholic acid (OCA) and our pipeline programs.
Core Accountabilities: The successful candidate must be able to perform each of the following satisfactorily
Drive the cross-functional decision-making process, in partnership with the global regulatory leader, for key regulatory filing milestones, by leveraging strong communication skills and experience with regulatory filing teams
Develop and coordinate a submission filing project plan for RegulatoryAffairs that integrates with the Integrated Project Plans and align with corporate objectives.
Manage and track the preparation of one or more marketing applications (e.g., NDA, sNDA, MAA)
Actively facilitate a risks/gap analysis and work with teams and functions on mitigation plans. As appropriate, escalate issues to the GRL and cross-functional leaders for further action
Facilitate regulatory filing team meetings with the global regulatory leader, prepare minutes, identify action items.
Follow up with team members as appropriate.
Develop and maintain key documents such as a MS Project filing plan
Ensure seamless communication within team, and between team and senior management
Partner with the cross-functional colleagues to ensure timely and high-quality development of key documents, including regulatory submissions, protocols, development plans, etc.
Work with finance department and cross-functional team, as needed, to track project budgets and resourcing needs and proactively flag issues; participate in annual budget and forecasts
Other duties as assigned Qualifications:
Bachelor's degree required
Minimum of 10 years of Regulatory Affairs and Project Management experience is required
PMP or RAC certification is desirable
Required Knowledge and Abilities:
Experience managing and tracking of US New Drug Applications (NDA), Biologics License Applications (BLA), and Investigational New Drug (IND) applications
Strong verbal and written communication skills are essential
A team player with strong influencing skills and problem-solving capabilities
Strong understanding of Drug Development Processes from strategic and operational perspectives (including regulatory understanding, clinical operations feasibility, etc.)
Ability to manage and direct work in a matrix environment; ability to work collaboratively across all levels of the organization
Ability to work in a fast-paced environment
Excellent organization and multi-tasking skills
Able to create, track and plan timelines and budgets
Strong command of MS Project
Proficient in Microsoft Excel, PowerPoint & Word
Travel as required to collaborate with global teams
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