Associate Director/Director Clinical Regulatory Writing, Cardiovascular, Renal Metabolism

About the position Responsibilities • Provide expert leadership to deliver submission communication strategies and drive the authoring of large clinical submission packages and other complex clinical documents. • Create robust clinical arguments through strong analytical and communications skills and critically evaluate clinical trial designs. • Be a proactive, independent, and innovative leader of large, complex teams. • Delegate and empower other internal and external writers, ensuring relevant regulatory, technical, and quality standards are achieved. • Effectively influence stakeholders and colleagues at the highest levels of a program to establish best communications practices. • Spearhead improvement initiatives at the therapeutic area or company-wide level. • Support the growth and development of the CVRM CReW community by mentoring less experienced writers. Requirements • An Advanced Degree (Master's Degree or equivalent) in a scientific field or appropriate subject area. • At least 6 years of proven experience in the medical/regulatory writing field in a pharmaceutical/biotech industry or CRO environment. • Broad cross-functional understanding of the drug development process from scientific, technical, and business perspectives. • Experience in leading large, diverse teams. • Excellent verbal and written communication skills in English. • Conceptual and strategic problem-solving ability with strong networking and influencing skills. Nice-to-haves • Ph.D in a scientific field with 8 years of proven experience. • Extensive knowledge of the latest technical and regulatory expectations. • Excellent organizational, analytical, decision-making, and interpersonal skills. Benefits • Diversity and inclusion initiatives • Opportunities for professional development • Mentorship programs Apply tot his job Apply To this Job