• Write high-quality clinical documents
• Identify the customers for each document, and formulate and convey key messages clearly and concisely
• Understand the key components/messages for regulatory submissions as embodied in FDA and ICH guidelines
• Use appropriate stylistic conventions

• Minimum of 5 years industry experience as a medical writer
• Specific vaccines experience
• Familiar with the drug development process and regulatory documentation
• Able to gather and synthesize large amounts of data
• Demonstrated ability to write clear, concise, and effective drug development documents
• Good team player; excellent written and verbal communication skills, and able to work well with others
• Able to meet timelines without compromising document quality
• Able to ensure consistency within and across documents
  Competency in relevant software applications

• Prepare regulatory documents (Investigator Brochures, clinical trial reports, NDA sections) according to agreed standards.
• Critically assess, interpret, and accurately summarize medical data.
• Contribute to the underlying strategy for achieving the most persuasive and effective presentation of data to the FDA to help ensure the optimal label for a product.
• Promote and exploit global working in the preparation of clinical contributions to regulatory dossiers.
• Provide innovative advice and guidance on planning and resource forecasting for dossier and document production to enable competitive deadlines.
• Interpret and monitor current and emerging communication issues and guidelines.
• Manage contract resources through the effective use of project management skills to ensure the delivery of quality documents.
  

Minimum Requirements

• Baccalaureate degree in biomedical discipline. - 3-5 years work experience
• Knowledge of the drug development process and human pathophysiology and diseases.
• Excellent written and oral communication skills, manifested as the ability to express medical information accurately, clearly, and succinctly.
• Demonstrated ability to manage several projects simultaneously, including dealing with risk and issue management.
• Knowledge of regulatory requirements and guidelines and standards.
• Influencing, interpersonal skills.
• Ability to travel nationally and internationally

Preferred Background

• Advanced biomedical degree
• Budget and resource management skills
• Knowledge of competitors and competitor products

Hours: Mon - Fri; 8:30am - 4:45pm