Description
Syneos Health is seeking a Medical Writer II (Clinical Trial Transparency). The successful candidate will have 1-3 years of experience in disclosure, knowledge of clinical research, clinical trials, and clinical registries.
Responsibilities:
- Compile, write, and edit medical writing deliverables
- Serve as a medical writer within and across departments with minimal supervision
- Develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and annual reports
- Review statistical analysis plans and table/figure/listing specifications
- Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs
- Adhere to established regulatory standards, including ICH-E3 guidelines
- Perform online clinical literature searches
- Continue professional development to keep pace with regulatory guidance and client expectations
Qualifications:
- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
- Client interaction experience
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Experience writing relevant document types
- Extensive knowledge of English grammar and ability to communicate clearly
Necessary Skills:
- 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