Project Manager 1, Medical Writing

Role: Project Manager within Global Medical Writing at BioMarin, overseeing drug development programs from early stages through post-approval. Responsibilities include developing integrated project plans, managing cross-functional collaboration, assessing risks, maintaining budgets and resources, and facilitating strategic decision-making. The role involves stakeholder engagement across Clinical Development, Regulatory, Data Sciences, and Safety teams, with a focus on ensuring project alignment and high performance. Qualifications: 3-6 years in drug development (pharma/biotech or CRO), with 1-3 years in project management for clinical phases; Bachelor's in Biological Sciences or related field; proficiency in project management tools such as MS Project, SharePoint, PowerBI, and Teams. Preferred: experience with drug development processes, regulatory submissions (IND to BLA/NDA), nonclinical study management, and PMP certification. High-value specifics: managing clinical development programs across phases, supporting regulatory compliance, and working within GxP environments. Work setup: not specified; the role encourages all qualified candidates to apply.