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
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