Principal Responsibilities and Accountabilities:
- Understand clinical data and utilizes this information to prepare written positions in support of clinical development.
- Responsible for capturing concepts and translation of concepts into written key messages to support synopsis development, protocol development, investigator brochures, clinical study reports in support of clinical execution and abstracts/manuscripts for medical conferences/medical journals.
- Create messages for abstracts and drafts content to support development of posters and slides for medical conferences.
- Familiar with the regulatory templates and content required to support clinical synopsis, clinical protocol, investigator brochures, Development Safety Update Report (DSUR), clinical sections of regulatory briefing documents, submission dossier (clinical module).
- Write, coordinate review process with subject matter experts, including QC/QA to assist in the finalization of the clinical and regulatory documents Investigators brochure (IB), protocols, Development Safety Update Report (DSUR), clinical sections of regulatory briefing documents, submission dossier (clinical modules).
- Familiar with requirement and process of medical manuscript preparation and review for peer journals.
- Organize literature searches and citations in support of clinical development programs, including medical manuscripts, posters, and regulatory documents.
- Closely communicate with medical, regulatory and clinical operations and communications team members.
- Masters level preferred
- Minimum of 5 years in role of medical writing
- Medical writing, knowledge of clinical research
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. Occasional travel up to 20%.
Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
Novan, Inc. is an equal opportunity employer and actively seeks candidates from diverse backgrounds including women, communities of color, the LGBT community, and people with disabilities.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.