Senior or Executive Director, Medical Writing

Celcuity

28d

About The Position

The Executive Director of Medical Writing provides strategic leadership for the medical writing function and partners with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Quality Assurance, Pharmacovigilance, Medical Affairs, and Executive Management. The role leads the planning, development, review, and delivery of evidence-based clinical and regulatory documents supporting global development and registration strategies. It ensures that documentation is accurate, compliant, and strategically aligned throughout the product lifecycle. The position drives operational excellence through departmental standards, processes, talent development, and resource management. It establishes goals and performance metrics, builds and retains a high-performing medical writing organization, and oversees external writing resources and vendors. The role also maintains document quality and inspection readiness, monitors changing regulatory expectations, and leads improvements and adoption of new technologies and approaches—including structured content, automation, and AI-enabled solutions where appropriate. Celcuity is a commercial biotechnology company developing targeted therapies for solid tumor indications. Its first FDA-approved product is REVTORPYK (gedatolisib), approved for adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting. Celcuity is also evaluating gedatolisib in clinical trials for breast and prostate cancer. The company is an equal-opportunity employer and offers competitive total compensation, including eligibility for an annual performance incentive bonus and a new-hire equity package, alongside benefits such as insurance, 401(k) match, PTO, and paid holidays.

Requirements

Advanced scientific degree (PhD, PharmD, MD, or equivalent).
15+ years of medical writing experience in 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 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.
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), 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.

Nice To Haves

Oncology drug development experience preferred.

Responsibilities

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 and foster accountability, collaboration, innovation, and scientific excellence.
Oversee external medical writing resources, vendors, and contract writers.
Direct planning, development, review, and delivery of clinical and regulatory documents in support of development and regulatory objectives.
Oversee 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.
Ensure consistency of scientific messaging across programs and submissions.
Collaborate with cross-functional stakeholders and align teams on document strategy, timelines, data interpretation, and key messages.
Influence decision-making and resolve complex issues through collaboration and stakeholder engagement.
Establish and maintain standards, processes, templates, and tools for 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 to improve the effectiveness, quality, and scalability of medical writing processes.
Lead implementation of technologies, systems, and innovative approaches, including structured content, automation, and AI-enabled solutions where appropriate.
Develop resource forecasts to support portfolio needs and organizational growth.
Ensure appropriate allocation of internal and external resources across programs and priorities.