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 Now
Apply Now
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 Now
Apply Now