Senior Manager/Associate Director, Medical Writing - Remote

Overview

The Senior Manager/Associate Director, Medical Writer is responsible for the medical writing deliverables that support the clinical portfolio at BBOT, collaborating cross-functionally to ensure key messages are consistently aligned in preparing clinical regulatory documents.

In Short

• Full-time position at a clinical-stage biopharmaceutical company.
• Responsible for preparing clinical study documents and regulatory submissions.
• Participate in strategic discussions for clinical document production.
• Collaborate with cross-functional teams to ensure document quality.
• Author and edit clinical documents within established timelines.
• Maintain high standards for scientific content and regulatory compliance.
• Review and ensure quality of documents prepared by others.
• Formulate critical messages from clinical study data.
• Represent Medical Writing across various programs.
• Perform additional duties as requested.

Requirements

• Bachelor’s degree in a life sciences discipline; advanced degree preferred.
• 7 years of experience in the biopharmaceutical industry, with 5 years in medical writing.
• Strong project and time management skills.
• Experience in developing clinical regulatory documents.
• Knowledge of IND/NDA/BLA/MAA submission requirements.
• Understanding of FDA/ICH guidelines and GCP.
• Proficiency in Microsoft Office and related software.
• Strong written and verbal communication skills in English.

Benefits

• Opportunity to work in a dynamic and fast-paced environment.
• Collaborate with leading scientists in drug development.
• Contribute to impactful work in oncology therapeutics.