Novan
  • 10-Apr-2018 to 09-Jun-2018 (CST)
  • Morrisville, NC, USA
  • Hourly
  • Contract

4 - 6 month contract position

Principal Responsibilities and Accountabilities:

  1. Understand clinical data in the clinical study reports (CSRs) and prepare manuscripts for medical journals.
  2. Create abstracts, posters, slides for medical conferences
  3. Familiar with requirement and process of medical manuscript for peer journals
  4. Organize literatures and citations related to the medical manuscripts, posters, regulatory documents, and corporate communications
  5. Closely communicate with regulatory and clinical team, and write, coordinate review process including QC/QA and finalize the clinical and regulatory documents Investigators brochure (IB), protocols, Development Safety Update Report (DSUR), clinical sections of regulatory briefing documents, submission dossier (clinical modules).
  6. Working closely with Regulatory Affairs, write and substantively edit regulatory documents including clinical sections of INDs and NDAs, regulatory meeting packages, annual reports, investigator brochures, pediatric study plans, waiver requests, and other regulatory documents.

 

Qualifications:

Education:

  • Master's degree preferred

 

Experience:

  • Minimum of 5 years writing medical reports for journals
  • Experience writing clinical sections of regulatory documents in support of INDs and NDAs

 

Skills:

  • Medical writing, expert 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 does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

Novan
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