[Hiring] Senior/Principal Medical Writer @Eldridge Writing

Role Description

We're seeking a Senior or Principal Medical Writer to join our collaborative, high-performing team. In this role, you will serve as a lead writer on complex regulatory and clinical documents, provide strategic program- and document-level input, and ensure high-quality deliverables that meet client and regulatory expectations. You'll own client relationships and programs, not just assignments, and approach the work with the judgment, initiative, and accountability of someone helping to build the business. You'll also play a key role in mentoring other writers, strengthening how we work, and helping us develop AI-optimized workflows that improve efficiency while preserving the quality, thoughtfulness, and regulatory rigor our clients expect.

This is a fully remote, full-time position with competitive compensation, benefits, and flexibility.

Key Responsibilities

• Serve as lead author on a range of regulatory and clinical documents, including protocols, clinical study reports (CSRs), investigator's brochures (IBs), briefing documents, investigational new drug (IND), and new drug application (NDA)/biologic license application (BLA) submission documents.
• Collaborate directly with clients and cross-functional teams to understand project goals and ensure clarity, consistency, and compliance in all written materials.
• Provide strategic input on document planning, content, and messaging.
• Review and edit documents prepared by colleagues, providing thoughtful feedback, strategic input, and quality control.
• Contribute to internal training, process improvements, and knowledge-sharing initiatives.
• Identify opportunities to improve how we plan, draft, review, and deliver client work, including thoughtful use of AI-enabled tools and workflows.
• Manage multiple projects with minimal oversight, balancing timelines, quality, and client expectations.

Qualifications

• At least 5 years of experience in medical writing within a pharmaceutical, biotechnology, or CRO setting.
• Demonstrated expertise in writing regulatory documents such as CSRs, protocols, IBs, briefing documents, and IND/NDA/BLA submission documents.
• Strong project management skills with the ability to manage timelines and multiple priorities independently.
• Excellent written and verbal communication skills, with attention to detail and scientific accuracy.
• Ability to provide constructive feedback to colleagues.
• Proficiency in Microsoft Office (especially Word) and familiarity with document templates and version control practices.
• Collaborative mindset, professionalism, and a commitment to exceptional client service.
• Entrepreneurial mindset, with the initiative to anticipate needs, solve problems, improve processes, and take ownership of work beyond a defined task list.

Preferred Qualifications

• Advanced degree (eg, MS, PhD, PharmD) in a life sciences or medical field.
• Experience working with small and mid-sized biopharma clients.
• Familiarity with FDA and ICH guidelines and industry best practices.
• Interest in applying AI tools to medical writing operations, including prompt development, quality control, workflow design, and responsible implementation in regulated-document processes.

Benefits

• Fully remote work environment with flexible hours.
• Competitive salary and benefits.
• Direct client access for projects you lead.
• Opportunities for leadership, career advancement, and professional growth.
• Company-sponsored participation in industry events.
• Supportive, small, collaborative team with a strong culture of quality and continuous learning, where your opinion and perspectives optimize how we work.
• A chance to help shape a growing company, mentor the next generation of medical writers, and build smarter, AI-optimized ways of working from the ground up.

How to Apply

If you're an experienced medical writer ready to take the next step in your career, we'd love to hear from you. Please submit your resume and a brief cover letter outlining your experience, interest in the role, and a project you're proud of and why.