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Senior Clinical Content Specialist
3 weeks ago
This is an exciting opportunity to work as a medical writer, where you will be responsible for creating high-quality clinical documents. Your primary goal will be to develop clear and accurate scientific information that meets regulatory requirements.
You will lead the completion of medical writing deliverables, ensuring that complex information is presented in a clear and concise manner. This will involve collaborating with cross-functional teams, including data management, biostatistics, regulatory affairs, and medical affairs.
Your responsibilities will also include performing online literature searches, complying with copyright requirements, and identifying solutions to resolve issues. Additionally, you will mentor and lead less experienced medical writers on complex projects.
This role requires strong presentation, proofreading, collaborative, and interpersonal skills. You should have a strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices. Experience writing relevant document types and extensive knowledge of English grammar are also essential.
Qualifications- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Strong presentation, proofreading, collaborative, and interpersonal skills
- Strong project and time management skills
- Strong proficiency in MS Office
- Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
