Medical Writer Job at LanceSoft in Denver

As a Medical Writer, you will play a crucial role in providing medical writing direction and guidance for various projects. Your expertise will ensure that all documentation aligns with the Company's style guide and meets the necessary regulatory standards (US and EMA). You will be responsible for the following :

Key Responsibilities :

• Provide medical writing directions and guidance aligned with the company's style guide for assigned projects, including the review of work products.
• Convert relevant data and information into formats that comply with TM document requirements and coordinate the review of the final products.
• Understand, assimilate, and interpret various sources of information with appropriate guidance and direction from the TM team.
• Confirm the completeness and accuracy of information presented in documents.
• Perform literature searches as needed to gather relevant content for drafting documents.
• Maintain expert knowledge of US and international regulations, requirements, and guidance associated with scientific publications, including US FDA and ICH guidelines.
• Utilize prior knowledge of preclinical strategy, pharmacology, toxicology, and GLP practices to ensure that documents drafted at the Company are prepared for regulatory inspection or audit in the US or Europe.
• Complete draft reports based on data provided by Company's Subject Matter Experts (SMEs) to ensure thoroughness and compliance.
• Review draft training modules on GLP's, regulatory writing and FDA interactions and provide suggestions on ways to modernize.

Qualifications :