Independently manage clinical regulatory writing activities across a complex portfolio of work
Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met
Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency
Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead
Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery
Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements
Demonstrate strategic thinking and review capabilities
Collaborate proactively with other functions at the program level
Support the development of Clinical Regulatory Writing Managers
Drive continuous improvement and operational excellence from a communications leadership perspective

BS Life Sciences degree in an appropriate discipline
Significant (7+ yrs) medical writing experience in the pharmaceutical industry or CRO
Ability to advise and lead communication projects
Understand drug development and communication process from development, launch through life cycle management
In-depth knowledge of the technical and regulatory requirements related to the role

Clinical Regulatory Writer – Associate Director

Key skills