Senior or Executive Director, Medical Writing
医疗写作执行主任为医学写作功能提供战略领导，并担任临床发展，监管事务，生物统计学，临床运营，质量保证，药物警和行政管理的关键伙伴。该职位负责规划，开发和交付基于证据的高品质的临床和监管文件，支持全球发展和注册策略的高绩效组织。执行董事通过强有力的标准，流程，人才发展和资源管理来推动运营卓越性，确保科学和监管文档准确，符合规范，并与产品生命周期中支持监管互动和知情决策的战略一致。责任：医疗写作领导和开发 · 在临床开发计划和监管提交过程中领导医学写作功能，根据需要与医疗事务合作在科学通信上。· 建立部门目标，优先事项和与企业目标相符的绩效指标。· 作为组织的医学写作专家和功能领导者。· 建立，发展和保持高绩效的医疗写作组织。· 培养责任感，合作，创新和科学卓越文化。·监督外部医疗写作的资源，供应商和合同作者。文件战略和跨职能伙伴关系。· 指导规划，开发，审查和提供支持开发和监管目标的临床和监管文档。· 监督关键成果，包括：· 临床研究协议和修正案 · 研究人员小册子 · 临终研究报告 · 监管简报文档。· 临床发展，监管事务，生物统计学，临床运营，质量保证，药品警等关键利益相关者合作。· 将团队协调文件战略，时间表，数据解释和关键信息。·通过有效的协作和利益相关者的参与影响决策并解决复杂问题。
查看英文原文
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.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.
Originally posted on Himalayas