Director, Medical Writing

Job description

About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The (job title) is responsible for timely delivery of high-quality clinical regulatory-compliant documents. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company. Please keep in mind that this is a full-time hybrid role with 3 days in the office in Warsaw, Poland. Key Responsibilities: Provide clear leadership and accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents. Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards. Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, qua...