Director, Regulatory Medical Writing, Oncology

About This Role

Lead regulatory medical writing initiatives for oncology, overseeing projects, mentoring writers, and ensuring compliance with regulatory guidelines. Drive strategic discussions and implement process improvements within a global healthcare innovation company.

Responsibilities

• Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals
• Proactively identify potential risks and develop strategies to mitigate them
• Recognize and resolve complex problems related to new service offerings and deliverables
• Write or provide guidance on all types of clinical, regulatory, and safety documents with complete independence
• Represent the Medical Writing department with decision-making authority in the R&D organization
• Lead or set objectives for team projects and tasks, including program-level, submission, indication, and disease area writing teams
• Serve as a liaison between team members and senior leadership within a TA or sub-function
• Develop, implement, and drive the institutionalization of departmental process improvements and best practices
• Mentor, support, and coach staff at all levels on document planning, processes, and content
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines

Requirements

• University/college degree in a scientific discipline
• 14+ years of relevant pharmaceutical/scientific experience
• 12+ years of relevant clinical/medical writing experience
• 5+ years of people management experience
• Experience providing strategic and operational leadership to medical writing teams
• Expertise in project management and process improvement
• Strong decision-making skills, strategic thinking, agility, broad vision

Qualifications

• A university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred.
• 14+ years of relevant pharmaceutical/scientific experience, 12+ years of clinical/medical writing experience, and 5+ years of people management experience.

Nice to Have

• Advanced degree (Masters, PhD, MD)

Benefits