Senior or Executive Director, Medical Writing

The Executive Director of Medical Writing provides strategic leadership for the medical writing function and serves as a key partner to Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Quality Assurance, Pharmacovigilance, and Executive Management. This role leads a high-performing organization responsible for the planning, development, and delivery of evidence-based, high-quality clinical and regulatory documents that support global development and registration strategies.

The Executive Director drives operational excellence through strong standards, processes, talent development, and resource management, ensuring that scientific and regulatory documentation is accurate, compliant, and strategically aligned to support regulatory interactions and informed decision-making across the product lifecycle.

Responsibilities:

Medical Writing Leadership and Development

• Lead the medical writing function across clinical development programs and regulatory submissions, partnering with Medical Affairs on scientific communications as needed.
• 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.
• Foster a culture of accountability, collaboration, innovation, and scientific excellence.
• Oversee external medical writing resources, vendors, and contract writers.

Document Strategy and Cross-Functional Partnership

• Direct the planning, development, review, and delivery of clinical and regulatory documents in support of development and regulatory objectives.
• Provide oversight for key deliverables, including:
• Clinical study protocols and amendments
• Investigator's brochures
• Clinical study reports
• Regulatory briefing documents
• IND, NDA, MAA submission components
• Clinical summaries and overviews
• Responses to health authority queries,
• Ensure consistency of scientific messaging across programs and submissions.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Quality Assurance, Pharmacovigilance, and other key stakeholders.
• Align teams on document strategy, timelines, data interpretation, and key messages.
• Influence decision-making and resolve complex issues through effective collaboration and stakeholder engagement.

Quality, Compliance, and Innovation

• Establish and maintain standards, processes, templates, and tools supporting efficient 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 and incorporate them into departmental operations.
• Drive initiatives that improve the effectiveness, quality, and scalability of medical writing processes.
• Lead implementation of new technologies, systems, and innovative approaches that enhance medical writing capabilities.
• Champion the adoption of structured content, automation, AI-enabled solutions, and industry best practices where appropriate.

Resource Management

• Develop resource forecasts to support portfolio needs and organizational growth.
• Ensure appropriate allocation of internal and external resources across programs and priorities

Qualifications:

• 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 the preparation and delivery of 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 other applicable ICH guidelines including but not limited to E3, E8 (R1), 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.

About Us:

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway.  REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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