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

Executive Summary

Just Strive is seeking a seasoned

Senior Medical Writer

with deep expertise in oncology and antibody-drug conjugates (ADC). This fractional, remote 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 Seniority level

Mid-Senior level Employment type

Contract Job function

Marketing, Public Relations, and Writing/Editing

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