Remote Executive Director, Medical Writer

Summary

Join a dynamic team at Syndax Pharmaceuticals as we search for an Executive Director, Medical Writing to provide scientific, leadership and operational expertise to the Medical Writing Team.

Responsibilities

• Provides leadership and oversees management of the medical writing function, building consistent processes to optimize utilization of resources aligned with company priorities
• Ensures Medical Writing activities and provision of deliverables are linked to program strategy by providing leadership and strategic input to projects/study teams at the organization level
• Ensures that documents meet quality standards in terms of scientific content, organization, clarity, accuracy, format, and consistency, and adherence to regulatory requirements and company guidelines/styles/processes
• Ensures that all activities are conducted in compliance with relevant regulatory requirements
• Leads medical writing team in designing and maintaining templates and standards for clinical documents in accordance with ICH guidelines and medical writing best practices
• Oversees documents created and edited by the Medical Writing function to ensure compliance with GCP, ICH guidelines, and eCTD requirements, and adherence to Syndax’s SOPs and style guide
• Creates, maintains, manages, innovates, and continuously improves medical writing procedures and SOPs; proactively identify opportunities to improve systems and processes and autonomously leads process improvement initiatives within the medical writing space
• Building and maintaining relationships with internal and external customers - playing a key role in business development-related activities and attending client meetings, writing and reviewing proposals, pricing deliverables, attending bid defense meetings, and contributing to contracts and work orders
• Developing financial forecasts, and monitoring revenue, costs & utilization. Providing regular business updates to senior leaders
• Responsible for driving and promoting organizational process improvement initiatives and creating an environment across the team that encourages others to initiate process improvements
• Collaborates cross-functionally with internal colleagues to improve quality and efficiency across projects and across the organization