Associate Director, Regulatory Medical Writing

Employer Industry: Biotechnology

Why consider this job opportunity:

• Salary up to $287,300
• Annual bonuses and equity awards available
• Comprehensive health and wellness programs, including medical, dental, vision, life, and disability insurance
• 401(k) company match and family support benefits
• Flexible work arrangements with the option for fully remote work
• Opportunity to lead and mentor a team in a collaborative environment

• Lead all medical writing deliverables for assigned compounds and indications
• Manage the work of both internal and outsourced medical writers
• Collaborate with the clinical team to develop document strategy and write necessary deliverables
• Oversee regulatory submissions and submission document writing
• Participate in process improvement initiatives and manage team development

• Bachelor’s degree required; advanced degree preferred
• Minimum of 8 years of relevant medical writing experience
• Expert knowledge of the clinical research process and regulatory writing
• Proficiency in MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems
• Thorough understanding of ICH GCP guidelines

• Experience managing medical writers
• Demonstrated ability to manage multiple projects successfully
• Interest in mentoring or leading people
• Strong leadership presence and decision-making capabilities
• Proven impact on patient lives through previous work

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