Senior Medical Writer/Principal Medical Writer

Accountabilities

• Lead the planning, development, review, and delivery of high-quality clinical documents while ensuring alignment with regulatory standards, internal procedures, and client expectations.
• Manage document development workflows from initial templates through final approval, coordinating effectively with sponsors, vendors, and internal project teams.
• Interpret clinical study data and independently develop clear, accurate key messages and scientific content.
• Apply strong medical writing expertise to produce complex regulatory documents while maintaining consistency, accuracy, and compliance.
• Conduct literature-based research to support clinical writing activities and strengthen document quality.
• Ensure all deliverables comply with applicable regulatory guidelines, including ICH, FDA, GCP, and eCTD requirements.
• Contribute to the improvement and maintenance of medical writing processes, templates, SOPs, and work instructions.
• Communicate effectively with internal stakeholders and clients to ensure alignment, resolve challenges, and deliver projects successfully.
• Manage multiple high-priority assignments while maintaining exceptional quality and meeting deadlines.

Requirements

• Extensive medical writing experience within pharmaceutical, biotechnology, or clinical research environments, along with strong regulatory knowledge and excellent communication skills.
• 5+ years of experience as a Senior Medical Writer in a sponsor or CRO environment, or 7+ years of experience as a Principal Medical Writer.
• Strong understanding of clinical development processes, regulatory requirements, and clinical trial documentation standards.
• Experience with ICH guidelines, FDA regulations, GCP requirements, clinical trial transparency requirements, and eCTD submission standards.
• Proven ability to independently author complex clinical documents and synthesize clinical data into meaningful content.
• Excellent written and verbal communication skills with the ability to collaborate effectively with clients and cross-functional teams.
• Exceptional attention to detail, organizational skills, and ability to manage multiple competing priorities.
• Ability to work independently with minimal supervision while maintaining high-quality standards.
• Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, Teams, and Adobe Acrobat.
• Advanced degree (MS/PhD) preferred.
• Experience in oncology and/or rare disease therapeutic areas, particularly protocol and CSR development, is a plus.

Benefits

• Competitive salary range of $101,800 - $184,700 USD depending on experience, qualifications, and location.
• Eligibility for a discretionary annual bonus program.
• Comprehensive health insurance benefits.
• Retail savings benefits.
• Life insurance and disability benefits.
• Parental leave support.
• Paid time off, including vacation and sick leave.
• Opportunity to work on impactful clinical research programs within a collaborative environment.
• Professional growth opportunities within a global healthcare and life sciences organization.