What are the responsibilities and job description for the Senior Medical Writer Job at The Emmes Company, LLC in Worcester position at The Emmes Company, LLC?
A company is looking for a Senior Medical Writer responsible for authoring and revising clinical and regulatory documents.
Key Responsibilities
Prepares IND applications, NDAs, MAAs, and other regulatory documentsLeads the development of clinical protocols, study reports, and investigator brochuresDevelops abstracts and primary manuscripts for publication and presentations at medical congresses
Required Qualifications
BS / BA degree in a scientific or health-related field; Masters, PharmD, or PhD preferredAt least 5 years of experience in clinical and regulatory submissions writingUnderstanding of clinical product development and regulatory environmentAbility to work collaboratively and coordinate team effortsIndependently motivated with strong organizational skills
