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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