Title: Medical Writer
Position Summary:
The contract medical writer in this role is responsible for the creation of English-language medical writing deliverables for our client's oncology and rare genetic disease programs, ensuring the high-quality, timely, and efficient development of clinical regulatory documents that comply with internal and external standards. This position is for an independent, proactive, experienced medical writer with demonstrated leadership in preparing clinical regulatory documents, reporting to the Associate Director of Medical Writing.
Key Responsibilities:
• Work with and lead project teams to prepare clinical regulatory documents, including protocols, CSRs, IBs, and DSURs, and clinical sections of INDs, NDAs, MAAs, and briefing documents, etc, according to company and agency guidelines in order to support drug development under strict timelines. This includes writing sections of clinical regulatory documents and managing others’ contributions to these documents.
• Work effectively with the company document management system and related tools, templates, and procedures in order to ensure efficient development of documents and dossiers.
• Ensure consistency in the method of development and style of presentation across clinical regulatory documents to maintain quality and ease of review.
Requirements:
• Substantial experience (7+ years) as a medical writer
• Fluent English speaker with exceptional writing skills.
• Dedicated to accuracy, with close attention to detail.
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
• Substantial experience in the preparation of clinical regulatory submission documents and maintenance of detailed knowledge of the requirements for their preparation.
• Excellent interpersonal skills with the ability to manage projects and stakeholders in a matrix organization.
• Ability to work both independently and collaboratively with a team in a cross-functional environment.
• Demonstrated leadership and problem-solving ability; experience resolving conflicting editorial opinions expressed by team members.
• Ability to prioritize effectively, work simultaneously on multiple projects, and complete high-quality documents on tight timelines.
• Experience writing in the areas of oncology, rare genetic diseases, or blood disorders is preferable.
• Experience with the advanced features of Microsoft Word and ability to work effectively with a document management system.
