13 days ago
My client is a global biopharmaceutical company developing targeted therapies for rare diseases. They recently succeeded in getting their first product approved, and are now growing quickly as the rest of their pipeline looks equally as promising. It is a fast-paced, high-energy organization promising great growth prospects and competitive compensation packages for individuals who are creative problem solvers and experts in their field.
Currently seeking a 'Senior Medical Writer' to fully prepare protocols, IBs, CSRs, and Summary Modules for Regulatory Submissions. Your responsibility would include the writing, reviewing and editing of these documents.
- Independently write first-draft content
- Produce clinical documentation for submission to regulatory authorities (NDAs and global marketing applications)
- Utilize clinical data, including text, tables and figures, appropriate to communicate the message effectively
- 5+ years of experience in pharmaceutical/biotech industries, specifically in medical writing
- Regulatory medical writing experience preferred
- Demonstrated ability to author high-quality writing in the English language
- Strong interpersonal skills and ability to work in a matrixed work environment
- Knowledge of Good Publication Practices and Guidelines for Authorship of the International Congress of Medical Journal Editors
- Understanding of regulatory requirements and ICH guidelines
This is a great opportunity if you are looking to make a difference and grow with a company whose dynamic and collaborative environment is supported by an outstanding pipeline.
Please direct all questions to m.villarreal @ hamlynwilliams.com or 347.305.7665.