This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for delivering expertise that aids in the creation of high-quality, purpose-driven clinical and regulatory documents.

• Document Writing: Oversees assigned writing projects and ensures compliance with applicable regulatory standards.

• Project/Program Management: Manages uncertainties to establish and oversee timelines for both individual and multiple documents.

• Process/Tool Establishment and Optimization: Recognizes opportunities for process and tool enhancement and implementation.

• Training and Mentoring: Guides the creation of new training programs and offers instruction to fellow MWs.

⛳️ Requirements

• An advanced degree (MS/PhD/PharmD/MD) in life sciences, pharmacy, medicine, or a health-related field is preferred.

• A bachelor's degree accompanied by at least 7 years of experience in regulatory document writing (or equivalent), a master's degree with 5+ years, or a PhD/PharmD/MD with a minimum of 3+ years of regulatory document writing (or equivalent) experience.

• Proficient technical skills in Microsoft Word, Adobe Acrobat, and electronic document management systems.

• Strong proficiency in Microsoft Outlook, Excel, PowerPoint, etc.