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

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