About the company
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Project Manager 1, Medical Writing based in the United States.
Responsibilities
- Project manage drug development programs for the Global Medical Writing organization across early-stage, late-stage, and post-approval phases.
- Integrate key workstreams supporting assigned products and programs, ensuring alignment across timelines, deliverables, dependencies, and stakeholders.
- Drive collaboration, transparency, and inclusive strategic planning while encouraging effective decision-making and critical thinking across project teams.
- Develop detailed project schedules that integrate key activities, timelines, milestones, dependencies, and critical paths.
- Develop and implement decision-making methodologies, tools, and solutions to identify and address complex project and program-level issues.
- Conduct project risk assessments, monitor emerging risks, and communicate appropriate escalations and mitigation strategies to relevant stakeholders.
- Monitor budget and resource requirements, maintain accurate financial and staffing information, and escalate changes or out-of-scope requirements when necessary.
- Partner with senior medical writing leadership to coordinate governance meetings covering strategy, emerging data, budgets, resourcing, and data-driven decisions.
- Manage SharePoint collaboration sites, dashboards, and related communication tools to support organizational alignment and visibility.
- Maintain and track organizational OKRs, ensuring progress remains visible and communicating changes, risks, and potential impacts.
- Facilitate effective team meetings and support the development of high-performing, collaborative project teams.
- Mentor or supervise junior team members when appropriate and contribute to additional organizational initiatives as assigned.
Requirements
- 3–6 years of professional experience in drug development within a pharmaceutical, biotechnology, or contract research organization environment.
- At least 1–3 years of direct project management experience supporting early- and/or late-stage clinical development programs.
- Bachelor's degree in Biological Sciences or a closely related discipline.
- Strong ability to facilitate effective team meetings, motivate cross-functional stakeholders, and build productive professional relationships.
- Excellent documentation, organizational, prioritization, and time-management skills, with the ability to manage multiple priorities in a fast-paced environment.
- Experience using Microsoft Project Professional or comparable project management software.
- Good understanding of the overall drug development process and the ability to work effectively across multidisciplinary development functions.
- Experience with nonclinical project management, particularly IND-enabling programs across multiple drug classes, is preferred.
- Familiarity with regulatory submission requirements from IND through BLA/NDA is preferred.
- Experience managing or monitoring nonclinical studies is an advantage.
- Proficiency with Microsoft Excel, SharePoint, Power BI, and Microsoft Teams is preferred.
- PMP certification or an equivalent project management credential is preferred.
- Strong communication, collaboration, problem-solving, and stakeholder-management skills.
Conditions
- Opportunity to contribute to drug development programs from early-stage research through post-approval activities.
- Remote work opportunity within the United States.
- Cross-functional exposure to Clinical Development, Regulatory, Data Sciences, Safety, Medical Writing, and other specialized teams.
- Opportunity to develop expertise in pharmaceutical project management and global clinical development.
- Collaborative environment with opportunities to support high-performing teams and mentor junior professionals.
- Exposure to complex, high-impact projects and data-driven decision-making.
- Opportunities for professional growth and expanded project leadership responsibilities.