Project Manager 1, Medical Writing

Responsibilities:
- Project manage drug development programs for the Global Medical Writing organization from early stage through post-approval.
- Facilitate integration of key workstreams supporting the product.
- Drive collaboration and transparency with inclusive strategic planning.
- Develop detailed project schedules, integrate key activities/timelines, and track the critical path.
- Develop decision-making methodologies, tools, and solutions to identify complex cross-functional issues with mid- to long-term impact.
- Manage project risk assessment and reporting to stakeholders.
- Ensure and analyze accurate budget and resourcing requirements; escalate change or out-of-scope needs.
- Partner with the Head of Global Medical Writing to schedule governance meetings on strategy, emerging data, budget/resourcing, and data-driven decisions.
- Manage SharePoint Team Collaboration Sites and associated dashboards.
- Maintain Global Medical Writing OKRs and communicate change, risk, and impact.
- May mentor and/or supervise junior staff.
- Other duties as assigned.

Required skills/qualifications:
- 3–6 years drug development experience (pharma/biotech or CRO), including 1–3 years direct project management in early and/or late stage clinical development.
- Ability to drive/motivate effective team meetings and high-performing teams; strong interpersonal relationships.
- Strong documentation, organization, and time management in a fast-paced environment.
- Experience with Project Professional.
- BS/BA in Biological Sciences or closely related field.

Desired skills:
- Experience in overall drug development process.
- 1–2 years nonclinical project management for IND-enabling (2+ drug class types).
- Familiarity with regulatory submission requirements (IND through BLA/NDA).
- Nonclinical study management/monitoring.
- Experience with Microsoft Excel, SharePoint, PowerBI, and Microsoft Teams.
- PMP certification preferred (or equivalent).