About This Role
Multiple Medical Writing openings are available, offering a great opportunity within a small Contract Research Organization (CRO). The Medical Writer is responsible for developing, reviewing, and editing clinical and regulatory documents for pharmaceutical, biotechnology, and medical device programs. This role involves close collaboration with clinical, regulatory, safety, and other cross-functional teams to ensure documents are accurate, consistent, scientifically sound, and compliant with regulatory requirements.
Responsibilities
- Prepare and edit regulatory and clinical documents for submission to health authorities
- Develop documents such as clinical study reports (CSRs), clinical protocols, investigator brochures, informed consent documents, safety reports, and regulatory submission materials
- Review and interpret clinical and scientific data and translate complex information into clear, concise, and well-organized documents
- Ensure documents follow applicable regulatory guidelines, company procedures, and client requirements
- Collaborate with clinical, biostatistics, data management, regulatory affairs, pharmacovigilance, and other project team members
- Manage multiple projects and timelines while ensuring high-quality deliverables
- Participate in document review cycles and incorporate feedback from internal and external stakeholders
- Perform quality control and consistency checks on assigned documents
- Support development and maintenance of templates, style guides, and standard processes
- Conduct literature and background research as needed to support document development
- Ensure appropriate referencing, formatting, and documentation of source materials
- Communicate project status, timelines, and potential issues to project teams and management
- Support client meetings and discussions related to assigned writing projects
- Stay current with applicable regulatory guidance and industry standards
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline; advanced degree preferred
- 2+ years of experience in medical or regulatory writing within a CRO, pharmaceutical, biotechnology, or related environment
- Experience writing clinical and/or regulatory documents
- Strong understanding of clinical development and the drug development process
- Knowledge of applicable regulatory guidelines and standards, including ICH and GCP
- Excellent scientific writing, editing, and proofreading skills
- Ability to interpret and communicate complex scientific and clinical information clearly
- Strong attention to detail and organizational skills
