Project Manager, REMS Team - Remote based in the US

Socket.dev; Morrisville (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Socket.dev is seeking an experienced Project Manager to lead REMS-focused projects in a CRO/Pharma environment. You will act as project lead and sponsor contact, overseeing quality, time, and cost while guiding the cross-functional team.

The role requires 3-5+ years REMS PM experience, Bachelor's degree, strong communication, financial acumen, and ability to navigate regulatory requirements.

Qualifications

• 8+ years of related project management experience.
• Bachelor's degree or equivalent in a relevant field.
• Experience in CRO/Pharma/Biotech environment preferred.

Responsibilities

• Serve as the primary sponsor contact for the project.
• Ensure timely, within-budget delivery and escalation pathways.
• Lead cross-functional project teams to meet deliverables.
• Manage contract scope, budget, and resource alignment.
• Communicate customer expectations and drive timelines.
• Identify risks and resolve issues at the project level.

Skills

Cross-functional leadership

Communication skills

Strategic thinking

Problem solving

Financial acumen

Education

Bachelor's degree or equivalent

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

PowerPoint

CTMS

Preclarus

Clarity

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position REQUIRES 3-5+ years of demonstrated REMS (Risk Evaluation Mitigation Strategy) Project Management experience within a CRO/Pharma/Biotech environment.

Join Us as a Project Manager - Make an Impact at the Forefront of Innovation

The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. The role involves leading the cross functional project team to meet or exceed deliverables.

What You'll Do:

• Serve as the primary contact between the sponsor and the organization at the project level.
• Ensure escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways).
• On projects where the scope requires, ensure clear delineation in responsibilities and communication pathways for secondary project leads, lead for a specific vendor(s) or subset of delivery.
• Accountable for the overall delivery of the cross-functional project (time, cost, quality).
• Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
• Establish, communicate and manage customer expectations to achieve optimal delivery during the project
• Drive Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Education & Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’).

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity)
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• Advanced therapeutic area knowledge and clinical development guidelines and directives
• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• Good judgment and decision making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations
• Ability to negotiate, persuade and influence others, including a cross cultural awareness.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.