DETAILED DUTIES & RESPONSIBILITIES:
* Write and edit clinical study reports, study protocols, investigator brochures, clinical data summaries, and other medical/regulatory documents.
* Serve as the primary medical writing representative on project teams and work closely with personnel from clinical, regulatory, and scientific departments.
* Develop and implement templates and formats for standardization of documents.
* Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide and poster presentations.
* Bachelor’s degree in a life sciences discipline and a minimum of 3 years biopharmaceutical industry experience.
* Experience preparing clinical regulatory documents and scientific publications is crucial.
* Must have a solid understanding of FDA/ICH guidelines and GCPs.
* Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with scientific graphing applications preferred.
* Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment.
* Background in oncology drug development is a plus.