Ref #: 22365

Employment type: Permanent - Full-Time

Location: US - Home Based

Posted: 25-Sep-2020


Principle Responsibilities:

• Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documentation.
• Contributes to project plan concerning organization and table layout for a specific document.
• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
• Review study concepts and edit protocols for consistency, progression, structure, and grammar.
• Review statistical analysis plans and incorporate into clinical study reports.
• Drive the document preparation process, receive and review primary statistical output, draft and distribute document for review, and compile comments and edits as necessary.
• Participate in team and client meetings as requested.

Education and Experience Requirements/Qualifications:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field
• Global regulatory submission experience.
• Excellent writing skills.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to prioritize multiple projects