Associate Director, Medical Writing

At Genmab, we are dedicated to building extraordinary futures by developing antibody products and groundbreaking medicines that change lives and the future of cancer treatment and serious diseases. The Associate Director, Medical Writing is responsible for contributing to the medical writing portfolio within the clinical and regulatory areas.

Requirements

• Author and review complex clinical and regulatory documents, including clinical trial protocols, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions
• Lead submission team activities and oversee the preparation of critical documents
• Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions
• Maintain up-to-date knowledge of relevant regulatory guidelines and requirements
• Adhere to guidelines, SOPs, practices, and technical standards in all aspects of work

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses