Senior Medical Writer/Principal Medical Writer
New
J
JobgetherPharmaceutical, Biotechnology
United StatesFull-TimeSenior
Salary$101,800 - $184,700 USD
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Job Details
- Experience
- 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.
- Required Skills
- GCPMicrosoft Office
Requirements
- Bachelor’s degree or equivalent in a scientific, medical, or related discipline with relevant medical writing experience.
- 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.
Responsibilities
- Lead the planning, writing, editing, formatting, and quality control review of clinical documents, including protocols, investigator brochures, informed consent templates, DSURs, clinical study reports, and patient narratives.
- 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.
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