Manager, Regulatory Medical Writing, Oncology

In this role, you will lead the planning, authorship, and coordination of complex regulatory and clinical documents supporting oncology programs while ensuring alignment with global standards and submission strategies:

• Lead the preparation, writing, and coordination of regulatory and clinical documents across oncology programs, ensuring scientific accuracy and compliance
• Act as lead medical writer and primary point of contact for cross-functional teams on assigned compounds and submissions
• Define document strategy, timelines, and content planning in collaboration with clinical, regulatory, and development stakeholders
• Facilitate cross-functional document review meetings and ensure alignment on scientific and regulatory messaging
• Mentor and coach junior medical writers, supporting capability development and quality standards
• Contribute to process improvement initiatives, best practices, and working groups within the medical writing function
• Ensure adherence to regulatory guidelines, internal standards, and submission requirements across all deliverables
• If in a managerial capacity, oversee team performance, staffing, development, and delivery quality

Requirements

This role requires deep expertise in regulatory medical writing within the pharmaceutical or biotech industry, particularly in oncology or complex therapeutic areas. Strong leadership, scientific rigor, and cross-functional collaboration are essential:

• Advanced degree in a scientific discipline preferred (PhD, MD, or Master’s degree strongly preferred)
• 8+ years of pharmaceutical or scientific experience, including at least 6 years in regulatory or clinical medical writing
• Strong experience leading or supporting oncology or complex therapeutic area submissions
• Deep understanding of regulatory guidance (e.g., ICH guidelines) and clinical development processes
• Proven ability to interpret and present complex statistical and clinical data with accuracy and clarity
• Experience working in matrixed, cross-functional environments with clinical, regulatory, and scientific stakeholders
• Strong leadership, mentoring, and project management capabilities
• Excellent written and verbal communication skills with high attention to detail
• Strong organizational skills with the ability to manage multiple priorities and deadlines effectively

Benefits

• Competitive base salary ranging from approximately $117,000 to $201,250 annually
• Eligibility for annual performance-based bonus and long-term incentive programs
• Comprehensive healthcare coverage including medical, dental, and vision insurance
• Retirement savings plans including 401(k) with employer support
• Paid time off including vacation, sick leave, holidays, parental leave, and additional family support benefits
• Life, disability, and supplemental insurance coverage options
• Flexible, global work environment with potential remote arrangements (case-by-case basis)
• Strong learning, development, and career growth opportunities in a global healthcare organization.