Project Manager 1, Medical Writing

About the role

This individual will identify and manage project-related priorities; maintain and track high-quality integrated project plans and dashboards to enable accurate reporting and decision making; enable effective team meetings and high-performance teams; manage risk assessment/escalation; develop strategies for monitoring progress and for intervention/problem-solving in collaboration with stakeholders. The Project Manager interacts with individuals within Global Medical Writing as well as across all departments ranging from Clinical Development, Regulatory, Data Sciences, and Safety.

Responsibilities

• Responsible for project managing programs from early stage to post-approval for the Global Medical Writing organization.
• Facilitates the integration of all key workstreams supporting the product.
• Drives collaboration and transparency, while influencing the team’s critical thinking with inclusive strategic planning.
• Develops detailed project schedules that integrate key activities, timelines, and tracks the critical path for assigned projects.
• Develops, independently and as part of a team, decision-making methodologies, tools, and solutions for the Global Medical Writing organization to identify complex issues with cross functional mid- to long-term project- and program-level impact.
• Manages project risk assessment and reporting to applicable stakeholders.
• Responsible for ensuring and analyzing accurate budget and resourcing requirements are maintained within Global Medical Writing, and escalating change or out of scope requirements.
• Partners with the Head of Global Medical Writing to schedule as-needed departmental Governance meetings to discuss strategy, emerging data, budget/resourcing, and align on data-driven decisions.
• Manages SharePoint Team Collaboration Sites and associated dashboards for the Global Medical Writing alignment and communication.
• Maintains Global Medical Writing OKRs (Objectives and Key Results), keeping the team on track and communicating change, risk and impact.
• May mentor and/or supervise junior staff.
• Other duties as assigned.

Experience Required

• 3–6 years of work experience in drug development (pharma/biotech or contract research organization), with a minimum of 1–3 years of direct project management experience in early and/or late stage clinical development.
• Ability to drive, motivate and enable effective team meetings and high performing teams, while developing and maintaining professional interpersonal relationships with colleagues.
• Strong documentation, organization and time management skills in a fast-paced environment.
• Experienced with Project Professional software.
• Minimum: Bachelor’s (BS/BA) in Biological Sciences or closely related field.

Desired Skills

• Experience in the overall drug development process.
• 1–2 years of nonclinical project management experience for IND-enabling (2+ drug class types).
• Strong familiarity with Regulatory submission requirements (IND through BLA/NDA).
• Experience with nonclinical study management/monitoring.
• Experience with Microsoft Excel, SharePoint, PowerBI (PBI) and Microsoft Teams.
• PMP certification preferred (or equivalent).

Ireland Safety Responsibility

• Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems.
• Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.