This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Medical Writing based in the United States.
This role offers a senior-level opportunity to lead the development of high-impact clinical, regulatory, and safety documentation across all phases of drug development and lifecycle management. The position plays a central role in translating complex scientific and clinical data into clear, submission-ready content that supports global regulatory approvals and communication with health authorities. Working within a collaborative, fast-paced environment, the Senior Manager will act as a key strategic partner to cross-functional teams including clinical development, regulatory affairs, and safety. This role combines hands-on medical writing expertise with leadership responsibilities, guiding document strategy, quality standards, and process improvements. It is well suited for someone who thrives at the intersection of science, communication, and regulatory excellence, particularly in the context of rare disease programs. The work directly contributes to advancing therapies that address significant unmet medical needs.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Medical Writing based in the United States.
This role offers a senior-level opportunity to lead the development of high-impact clinical, regulatory, and safety documentation across all phases of drug development and lifecycle management. The position plays a central role in translating complex scientific and clinical data into clear, submission-ready content that supports global regulatory approvals and communication with health authorities. Working within a collaborative, fast-paced environment, the Senior Manager will act as a key strategic partner to cross-functional teams including clinical development, regulatory affairs, and safety. This role combines hands-on medical writing expertise with leadership responsibilities, guiding document strategy, quality standards, and process improvements. It is well suited for someone who thrives at the intersection of science, communication, and regulatory excellence, particularly in the context of rare disease programs. The work directly contributes to advancing therapies that address significant unmet medical needs.
Accountabilities:
- Lead the authoring, review, and coordination of regulatory, clinical, and safety documents including protocols, protocol amendments, CSRs, IBs, CTD modules, briefing documents, and submission materials.
- Translate complex clinical, scientific, and regulatory data into clear, accurate, and submission-ready documents that meet global regulatory expectations.
- Manage end-to-end document development processes, including timelines, review cycles, and resolution of stakeholder comments to ensure on-time delivery.
- Partner closely with cross-functional teams to ensure consistency, scientific accuracy, and regulatory compliance across all written deliverables.
- Ensure adherence to applicable FDA, EMA, ICH, and other global regulatory guidelines and industry standards.
- Lead or contribute to the development and continuous improvement of medical writing processes, templates, style guides, and SOPs.
- Provide strategic medical writing expertise across clinical development and post-marketing activities, supporting regulatory strategy and submission readiness.
- Maintain deep therapeutic and product knowledge to support high-quality scientific communication and documentation.
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or a related field required; advanced degree (MS, PharmD, PhD) preferred.
- 7+ years of experience in medical writing, regulatory writing, document management, or related roles within biotech, pharma, CRO, or healthcare environments.
- Proven experience authoring complex clinical and regulatory documents supporting drug development and regulatory submissions.
- Strong understanding of global drug development processes and regulatory requirements (FDA, EMA, ICH, and others).
- Demonstrated ability to independently manage complex writing projects, prioritize effectively, and meet tight deadlines.
- Exceptional scientific writing, editing, and communication skills with strong attention to detail and quality.
- Experience collaborating effectively with cross-functional stakeholders in a matrixed environment.
- Proficiency with Microsoft Office and familiarity with document management systems (e.g., Veeva or similar platforms).
- Strong interpersonal skills with the ability to communicate complex scientific content to both technical and non-technical audiences.
- Adaptability to shifting priorities and evolving project requirements in a fast-paced development environment.
- Competitive base salary range: $132,000 – $172,000.
- Short-term incentive bonus and long-term equity (stock) compensation.
- Comprehensive health, dental, and vision insurance coverage.
- Retirement savings plan with employer matching contributions.
- Life insurance and disability benefits.
- Generous paid time off and paid holidays.
- Wellness programs and employee assistance resources.
- Flexible work-life balance support and comprehensive employee well-being offerings.