Project Manager 1, Medical Writing

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.

This role offers the opportunity to manage critical drug development programs supporting global medical writing activities from early-stage development through post-approval.

You will coordinate complex workstreams, timelines, resources, risks, and priorities across multidisciplinary clinical development teams.

The position combines structured project management with strategic problem-solving and cross-functional collaboration.

You will create integrated project plans and dashboards that enable accurate reporting, informed decision-making, and effective execution.

Working with teams across Clinical Development, Regulatory, Data Sciences, Safety, and other functions, you will help maintain alignment throughout the development lifecycle.

You will also contribute to governance, resource planning, performance tracking, and continuous improvement across the medical writing organization.

This is an opportunity to make a meaningful impact within a collaborative environment focused on advancing therapies for patients with serious and rare conditions.

Accountabilities

• 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.

Benefits

• 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.