Job Description

The Medical Writing consultant will act as primary contact for medical writing projects. Some typical job duties include:

• Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to:
  • NDA's
  • CSR's
  • Safety Evaluation Reports
  • Medical literature analysis reports

Qualifications

• BA/BS degree
• 5 years Regulatory Writing expereince
• Demonstrated experience in the development of regulatory/ clinical submissions (preferably as a medical writer for pharmaceutical industry

Desired Qualifications

• Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH). Experience as author or contributor of peer-reviewed manuscripts is strongly desired.
• Strong verbal, written, and interpersonal communication skills.
• Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote.
• Therapeutic expereince in CNS (Alzheimers and Narcolepsy)

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