Senior Medical Writer

Position Purpose:

• The Senior Medical Writer (Sr MW) writes/edits clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other documents for submission to the Food and Drug Administration (FDA) and other regulatory authorities; and develops abstracts, manuscripts, and presentation materials summarizing clinical data.

Primary Duties:

• Write/edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
• Develop manuscripts and presentation materials
• Develop and manage timelines for document development
• Coordinate multi-document projects
• Represent medical writing on study teams and cross-functional strategic teams
• Work on problems of diverse scope where decisions are based upon a mixture of analysis, wisdom, experience, judgment, and rigorous logic and methods
• Acts independently to determine methods and procedures on new assignments action
• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
• Adhere to EP and Client SOPs and processes

Skills and Education:

• BA/BS in life sciences and a minimum of 5 years’ experience or MS/PhD and a minimum of 2 years’ experience
• Module 2 writing experience required
• Solid understanding of FDA/ICH guidelines and GCPs
• Experience preparing clinical regulatory documents and scientific publications
• Expert abilities in Microsoft Word, Excel and PowerPoint
• Experience with Adobe Acrobat
• Prior NDA/BLA/MAA submission experience
• Strong written and verbal communication skills
• Ability to coordinate and prioritize multiple projects in a fast-paced environment
• Ability to anticipate and address issues with potential to impact timelines