REMS Project Manager

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🔥 3 hours ago

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope • 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

🎯 Requirements

• 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