Senior Executive Director, Medical Writing

🕒 3 days ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Provide strategic leadership for the medical writing function • Partner with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Quality Assurance, Pharmacovigilance, and Executive Management • Lead planning, development, review, and delivery of clinical and regulatory documents • Establish departmental goals, priorities, and performance metrics aligned with corporate objectives • Serve as the organization's medical writing expert and functional leader • Build, develop, and retain a high-performing medical writing organization • Oversee external medical writing resources, vendors, and contract writers • Direct document strategy and ensure consistent scientific messaging across programs and submissions • Oversee clinical study protocols and amendments, Investigator's Brochures, Clinical Study Reports, regulatory briefing documents, IND/NDA/MAA submission components, clinical summaries and overviews, and responses to health authority queries • Collaborate with cross-functional stakeholders to align document strategy, timelines, data interpretation, and key messages • Influence decision-making and resolve complex issues through stakeholder engagement • Establish and maintain standards, processes, templates, and tools for document development • Ensure deliverables comply with regulatory requirements, industry standards, company policies, and SOPs • Maintain inspection readiness and support adherence to GCP and applicable regulatory guidance • Monitor evolving regulatory expectations and industry best practices • Drive improvements in the effectiveness, quality, and scalability of medical writing processes • Lead implementation of new technologies, systems, structured content, automation, and AI-enabled solutions • Develop resource forecasts and allocate internal and external resources across programs and priorities

🎯 Requirements

• Advanced scientific degree (PhD, PharmD, MD, or equivalent) • 15+ years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry, including leadership experience • 8+ years of progressive leadership experience managing medical writing teams and complex development programs • Demonstrated success leading major regulatory submissions, including INDs, NDAs, MAAs, and responses to health authority inquiries • Extensive experience authoring, reviewing, or overseeing clinical and regulatory documents, including protocols, Investigator's Brochures, Clinical Study Reports, clinical summaries, and regulatory briefing materials • Strong knowledge of drug development • Oncology drug development experience preferred • Proven ability to lead cross-functional teams, influence stakeholders, and manage competing priorities • Experience managing internal teams and external medical writing vendors or contractors • Strong understanding of global regulatory requirements, ICH E6 (R3) GCP, and applicable ICH guidelines including E3, E8 (R1), and M11 • Experience establishing processes, standards, and operational improvements that enhance quality, efficiency, and scalability • Demonstrated ability to manage multiple priorities and deliver results in a fast-paced, evolving environment

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays