Senior Medical Writer Oncology & ADC Focus (Remote/Fractional)

Company Description

Just Strive is a management strategy consulting firm exclusively focused on Biotechnology, Pharmaceuticals, and Medical Devices. We help early-stage and growth-stage companies translate innovation into execution, aligning scientific, regulatory, and commercial strategies to accelerate development and unlock enterprise value. Our ethos is rooted in clarity, ambition, and disciplined progress. Our work spans six integrated domains: program and alliance management, portfolio strategy, drug development acceleration, regulatory and commercial readiness, organizational design, and strategic business development. Whether a start-up is preparing for IND submission, scaling clinical operations, or positioning for licensing partnerships, Just Strive delivers hands-on support that turns complexity into traction. If you're a seasoned biotech professional ready to contribute in a remote fractional capacity, we invite you to explore this opportunity and see how your expertise aligns with our mission. Come join us in building clarity, momentum, and lasting impact. Executive Summary: Just Strive is seeking a seasoned Senior Medical Writer with deep expertise in oncology and antibody-drug conjugates (ADC). This fractional role supports high-impact regulatory and clinical documentation across Modules 2 and 5, with a focus on safety and efficacy narratives. Ideal candidates bring at least 10 years of progressive authoring experience and thrive in fast-paced, cross-functional biotech environments. Key Responsibilities:

• Lead the authoring of Module 2 (CTD Summaries) and Module 5 (Clinical Study Reports, Safety Narratives, and Efficacy Narratives) for global regulatory submissions, ensuring scientific rigor and regulatory alignment
• Draft, structure, and refine safety and efficacy narratives that accurately reflect clinical outcomes, adverse event profiles, and therapeutic benefit, particularly in oncology and ADC programs
• Interpret complex clinical data—including PK/PD, biomarker analyses, and dose-escalation findings—and translate them into clear, regulator-ready documents
• Collaborate closely with clinical development, biostatistics, regulatory affairs, and pharmacovigilance teams to ensure consistency, accuracy, and strategic messaging across all deliverables
• Contribute to the development of investigator brochures, protocols, briefing documents, and IND/BLA/NDA components, with a focus on oncology trial design and ADC-specific considerations
• Apply deep understanding of oncology mechanisms of action, therapeutic targets, and ADC payload/linker technologies to contextualize clinical findings and support regulatory positioning
• Ensure all documents adhere to ICH, FDA, EMA, and other global regulatory standards, while maintaining clarity, scientific integrity, and alignment with program strategy
• Participate in cross-functional content planning, gap analysis, and document review cycles to support submission readiness and milestone achievement

Experience Requirements

• Minimum 10 years of progressive medical writing experience in the biotechnology or pharmaceutical industry, with a strong focus on oncology
• Demonstrated expertise in authoring regulatory documents for global submissions, including Module 2 (CTD Summaries) and Module 5 (Clinical Study Reports, Safety and Efficacy Narratives)
• Proven ability to craft safety and efficacy narratives that synthesize clinical data, adverse event profiles, and therapeutic outcomes with clarity and regulatory precision
• Experience supporting oncology programs, including solid tumors, hematologic malignancies, or immuno-oncology; ADC experience strongly preferred
• Deep familiarity with clinical trial design, dose-escalation strategies, PK/PD interpretation, and biomarker integration
• Strong understanding of ICH, FDA, EMA guidelines and submission standards
• Track record of cross-functional collaboration with clinical development, regulatory affairs, pharmacovigilance, and biostatistics teams
• Exceptional scientific writing skills with the ability to translate complex data into compelling, regulator-ready narratives

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