Project Manager - PV & Risk Management

BioPoint Inc; Cambridge (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

BioPoint, Inc. is seeking a seasoned Project Manager to drive risk-based delivery in life sciences projects in Cambridge, MA. You will assess scope, timelines and coordinate with internal teams and external vendors to keep milestones on track.

Candidates should have 5+ years in biotechnology or pharmaceutical industries, excellent communication, and familiarity with ICH guidelines. The role emphasizes cross‑functional collaboration, reporting and process improvement.

Qualifications

• BA/BS degree or higher preferred.
• 5+ years’ experience within the biotechnology/pharmaceutical industry.
• Understanding and familiarity with ICH guidelines is a plus.

Responsibilities

• Continually identify, prioritize and mitigate project risks
• Meet with appropriate personnel for periodic reviews
• Produce reports showing progress against outstanding milestones, resource requirements, issues, risks and dependencies
• Provide oversight and control of any external resources contracted to the project
• Research and identify solution opportunities
• Define project scope and objectives
• Estimate time requirements, establish deadlines and monitor milestone completion
• Lead project teams to create and maintain project schedules, complete project deliverables and track progress against deadlines
• Collaborate with internal and external resources and subject matter experts
• Other duties as assigned

Skills

Process Management

Analytical thinking

Communication skills

Change management

Cross-functional collaboration

Education

BA/BS degree

Tools

Microsoft Office

Project management software

Job description

BioPoint, Inc.is a leading global strategic consulting firm that combines deep life sciences industry knowledge with specialized expertise in drug safety, health economics and outcomes research, regulatory affairs, quality assurance, compliance and risk mitigation. Our professionals can and have assisted clientsin optimizing their businesses, improve their operations and risk profile, and advance their organizational performance to seizekey opportunities.

Job Description

Continually identify, prioritize and mitigate project risks

Meet with appropriate personnel for periodic reviews

Produce reports showing progress against outstanding milestones, resource requirements, issues, risks and dependencies

Provide oversight and control of any external resources contracted to the project

Research and identify solution opportunities

Define project scope and objectives

Estimate time requirements, establish deadlines and monitor milestone completion

Lead project teams to create and maintain project schedules, complete project deliverables and track progress against deadlines

• Utilizing interpersonal and change management skills, overcome resistance to new processes to ensure maximum efficiency
• Elicit detailed requirements using interviews and document and business process analysis
• Develop requirements specifications according to standard templates, using natural language simply, clearly, unambiguously, and concisely
• Develop functional and system design specifications by critically evaluating information gathered from multiple sources, reconciling conflicts, decomposing high-level information into details, abstracting up from low-level information to a general understanding, and distinguishing user requests from the underlying true needs
• Collaborate with internal and external resources and subject matter experts
• Other duties as assigned

Job Requirements:

• BA/BS degree, or higher, preferred
• 5+ years’ experience within the biotechnology/pharmaceutical industry required
• Understanding and familiarity with ICH and other international guidelines is a plus

o Minimum 1-3 years of process or project management experience as a project manager or a related role, with demonstrated success in leading process or project initiatives through a project lifecycle.

o Ideally this person has some Pharmacovigilance / Drug Safety experience or equivalent.

• Outstanding communication skills (verbal and written)
• Strong analytical, assessment, judgment, and problem solving skills
• Outstanding interpersonal skills and professionalism
• Ability to work independently, as well as within a cross-functional team environment
• Ability to work in a dynamic environment and manage competing priorities
• Knowledge and experience of common safety database systems
• Proficiency in Microsoft Office and Project management software
• May require some domestic and/or international travel (<10%)

Qualifications

• Process Management – Proficient at figuring out the process necessary to get things done; knows what to measure and how to measure it; understands how to separate and combine tasks into efficient work flow; can see opportunities for synergy and integration; can simplify complex processes
• Innovation Management – Good at bringing creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace
• Problem Solving – Uses logic and methods to solve problems with effective solutions; probes applicable sources; looks beyond the obvious and doesn’t stop at the first answers
• Perspective – Looks toward a broad view of an issue/challenge; can easily pose future scenarios; can think globally; can discuss multiple aspects and impacts of issues and project them into the future
• Listening – Practices attentive and active listening