Associate Director, Regulatory Medical Writing

Role Summary

Associate Director, Regulatory Medical Writing will represent Medical Writing and provide leadership across compound areas, oversee junior writers, and assist in leading regulatory submissions. We work closely with senior Medical Writing management to help produce and ensure adherence to department guidelines, templates, standard timelines, and SOPs that follow regulatory guidelines. Responsibility will also include managing and developing staff; this may include performance management and training. Additionally, you will independently write all in-scope clinical documentation in their compound areas. This position can be either fully remote or on-site at our Sleepy Hollow, NY or Warren, NJ offices.

Responsibilities

• Leads all MW deliverable work for assigned compounds/indications
• Manages work of both internal and outsourced Medical Writers
• Works with clinical team to develop document strategy and write in-scope deliverables as needed
• Develop and articulates document strategy and timelines
• Identifies appropriate decision makers, focuses on results/actions
• Leads regulatory submissions/submission document writing
• Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development
• Participates in new initiatives within MW and throughout Global Development
• Manages processes and organize priorities; solves problems; fosters collaboration to resolve conflict
• Leads, challenges, and develops MW team
• Manages and develops staff; this may include performance management, recruiting, coaching, and training
• Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
• Remains compliant with internal training

Qualifications

• Minimum of 8 years’ relevant Medical Writing experience (relevant advanced degree may offset some of the experience requirement)
• Expert knowledge of the clinical research process and regulations/guidelines and regulatory writing
• Expert clinical document reading, writing, and editing experience
• Any experience managing medical writers is helpful
• Proficiency in MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems
• Thorough understanding of ICH GCP guidelines

Education

• Bachelor’s degree required; advanced degree preferred