UBC · 1 hour ago
REMS Project Manager
United States
Full-time
Hybrid
Mid, Senior LevelUBC is a pharmaceutical support industry leader devoted to empowering health solutions for a better tomorrow. The REMS Project Manager will oversee all aspects of project conduct, ensuring projects are delivered on time, on budget, and within scope while managing project teams and client relationships.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
Oversee all aspects of project conduct from start-up through close-out
Execute operational aspects of assigned project activities as well as special projects
Manage project per the scope of work and within the contracted budget
Manage revenue and invoicing for project(s)
Ensure project is conducted according to UBC SOPs and client SOPs as applicable
Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans
Prepare project timelines and prepare or coordinate development of deliverables
Prepare project meeting agendas and create minutes and actions logs
Ensure project budget is tracked against contract milestones
Serve as UBC primary contact with sponsor
Coordinate and facilitate all project meetings with internal and external stakeholders as necessary
Focal point for resolving project team member questions
Supervise all functional areas that support the project
Lead projects with cross functional involvement and supervise all functional areas that support the project
Ensure project training occurs and assist with training for project, as assigned
Develop content and lead Kick off Meetings both internally and externally
Negotiate budgets and assist with remediation of contract language
Present project information at bid defenses, client meetings and UBC monthly project review meetings
Maintain project documentation to be 'audit ready'
Participate in sponsor/regulatory audits as required
Coordinate investigator meeting as required
May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
Help lead process improvement activities
Establish, implement and track key metrics to report on progress of project and initiatives
Coordinate and ensure maintenance of Trial Master File as required
May be asked to perform CSS and CRA duties as needed
Other duties as assigned by management
Qualification
Required
Bachelor's Degree or equivalent experience
Previous managerial, or relevant experience, required
Very good written verbal and non-verbal communication skills
Very good supervisory skills
Very good interpersonal skills
Very good presentation skills
Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
Solution driven
Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
10% travel as required
Benefits
Remote opportunities
Competitive salaries
Growth opportunities for promotion
401K with company match
Tuition reimbursement
Flexible work environment
Discretionary PTO (Paid Time Off)
Paid Holidays
Employee assistance programs
Medical, Dental, and vision coverage
HSA/FSA
Telemedicine (Virtual doctor appointments)
Wellness program
Adoption assistance
Short term disability
Long term disability
Life insurance
Discount programs
Company
UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access.
Founded in 2003
1001-5000 employees
H1B Sponsorship
UBC 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
2021 (5)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
$0.04M2017-11-27Acquired
2010-08-13Series Unknown· $0.04M
Leadership Team
Bekki Brown
Chief Operating Officer
Nicole Hebbert
SVP, Head of Patient Support Services
Recent News
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