Senior Manager, Regulatory and Medical Writing

📋 Description

• Serve as a senior subject matter expert in regulatory and medical writing, maintaining a strong
• Provide guidance and mentorship to medical writers and managers, supporting professional
• Provide immediate supervision to assigned team members, including allocating work, reviewing
• Lead or contribute to departmental initiatives and strategic projects, taking ownership of
• Act as a document subject matter expert across complex regulatory and medical writing deliverables
• Support and mentor colleagues in the use of quality control processes, medical writing tools

🎯 Requirements

• Hold a college degree in a scientific, medical, clinical, or related discipline, with a master’s
• Bring at least 6 years of experience in Regulatory and Medical Writing or a closely related field
• Have proven direct experience managing, mentoring, and developing Medical Writing professionals
• Demonstrate strong managerial capabilities, with the ability to assign work, develop talent
• Possess a strong understanding of regulatory requirements and guidance relevant to medical writing
• Bring hands-on knowledge of clinical trials, pharmaceutical development, scientific and clinical

🎁 Benefits

• Fully remote opportunity within the United States.
• Opportunity to work in a collaborative, supportive, and innovative clinical research environment.
• Leadership role with meaningful responsibility for team development, mentoring, and departmental
• Exposure to complex regulatory and medical writing programs supporting pharmaceutical
• Opportunities to work with evolving medical writing technologies, including AI-assisted authoring
• Professional development and career growth through subject matter expertise, leadership