Associate Director, Medical Writing

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

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💵 $200k - $220k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 0%

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Logo of Latigo Creative

Latigo Creative

1 - 10 employees

Founded 2017

📣 Marketing

📱 Media

🤝 B2B

Marketing • Media • B2B

Latigo Creative is a design and branding company that develops visual identities and cohesive brand experiences for businesses. They provide graphic and packaging design, logo/identity creation, print and event collateral, signage and POS, art direction, 3D product visualization and photography, web design and WordPress development, video and motion graphics, and social media and digital strategy. Latigo emphasizes collaboration with agency partners and stakeholders to deliver consistent, effective creative across physical and digital channels.

📋 Description

• Author, review, and manage clinical development and regulatory documents, including protocols, protocol amendments, CSRs, investigator brochures, briefing documents, and clinical sections of regulatory submissions • Lead document planning, development, review cycles, and comment resolution to ensure on-time, high-quality deliverables • Collaborate with Clinical Development, Clinical Operations, Statistics, Clinical Pharmacology, Regulatory Affairs, and other stakeholders to interpret and communicate complex scientific, clinical, statistical, and pharmacology data • Develop and maintain templates, style guides, document standards, and best practices • Ensure compliance with FDA regulations, ICH guidelines, GCP, and other applicable regulatory requirements • Contribute to INDs and other global regulatory submissions, including regulatory responses and supporting documentation • Support process improvement initiatives that enhance medical writing quality, consistency, and scalability • Serve as a medical writing subject matter expert within cross-functional project teams

🎯 Requirements

• Master's degree or higher in life sciences, pharmacy, nursing, health sciences, or a related scientific discipline • Minimum 8 years of medical writing experience in the biotechnology, pharmaceutical, or CRO industry • Demonstrated expertise authoring clinical study protocols and clinical study reports • Experience supporting INDs, CTAs, and/or other regulatory submissions • Strong understanding of clinical drug development and regulatory requirements • Experience with clinical pharmacology content is preferred • Excellent scientific writing, communication, organizational, and project management skills • Ability to manage multiple projects and competing priorities in a fast-paced environment • Willingness to travel periodically for team meetings and other business needs • Flexibility to support occasional extended hours during periods of intensified activity and submission-related deadlines

🏖️ Benefits

• Remote work arrangement • Periodic travel for team meetings and other business needs • Flexibility to support occasional extended hours during intensified activity and submission-related deadlines

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