Medical writer

• Prepare high-quality regulatory documentation for client submissions
• Contribute to authorship of documents across different service lines
• Lead projects and author regulatory documents for client engagements
• Mentor others in regulatory document authoring
• Author and lead Modules 3 and Module 2.3
• Serve as document lead for submission-level documents
• Provide subject matter guidance on document preparation, review, comment resolution, and finalization
• Lead project teams toward goals within timelines and budgets
• Build professional client relationships and support business relationships
• Identify and institutionalize effective work practices
• Resolve sensitive or high-pressure project problems
• Transfer knowledge across the organization

Principal Medical Writer – CMC Focus

• Prepare high-quality documentation for regulatory submissions to streamline the regulatory documentation process for clients
• Contribute to authorship of various documents across different service lines
• Lead projects and contribute as an author for all types of client engagements
• Mentor others in authoring regulatory documents
• Lead submission-level sections for clinical documents, including Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE
• Lead sub-teams for pharmacovigilance and transparency and disclosure deliverables
• Take responsibility for clarity of purpose and lead others toward common goals within timelines and budgets on complex projects
• Manage crisis communications and risks
• Identify and promptly address potential problems, particularly in sensitive or high-pressure situations
• Integrate expertise across multiple therapy areas to deliver business successes and transfer knowledge across the organization

Principal Medical Writer – Clinical Focus

• Independently plan and prepare a range of regulatory documents and medical communications supporting all phases of product development.
• Organize, analyze, interpret, and present scientific and statistical information in accordance with ICH and other regulatory guidelines and company document standards.
• Work under the direction of Medical Writing management.
• Collaborate with cross-functional internal and external document production teams.