Principal Medical Writer – CMC Focus

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Generate high-quality regulatory documents for client submissions.

• Participate in the authorship of documents across various service lines.

• Oversee projects and author regulatory documents for client engagements.

• Provide mentorship to others in the authoring of regulatory documents.

• Author and lead Modules 3 and 2.3.

• Act as the document lead for submission-level documents.

• Offer subject matter expertise on document preparation, review, comment resolution, and finalization.

• Guide project teams to achieve goals within established timelines and budgets.

• Foster professional client relationships and enhance business partnerships.

• Recognize and implement effective work practices.

• Address sensitive or high-pressure project challenges.

• Facilitate knowledge transfer across the organization.

⛳️ Requirements

• Bachelor’s degree or higher, preferably in a scientific discipline.

• Over 7 years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation.

• Experience in vaccines, gene/cell therapy, biologics, small molecules, manufacturing, analytical, or stability.

• Familiarity with NDAs, INDs, BLAs, or IMPDs.

• Proven experience in authoring and leading Modules 3 (e.g., Modules 3.2.S and 3.2.P) and Module 2.3.

• Knowledge of regulatory authority guidelines and requirements.

• Capability to lead a project team.

• Understanding of regulatory requirements for various phases of development and regulatory pathways.

• Awareness of global health authority requirements.

• Experience as a document lead on submission-level documents.

• Intermediate proficiency in Microsoft Word, including editing tools, creating and modifying tables, inserting figures, and document management techniques.

• Strong grasp of document creation processes and the drug development lifecycle.

• Ability to synthesize data from multiple sources and documents to prepare summary reports.

• Expertise in quality document preparation, including document review, comment resolution/incorporation, and finalization.

• Capability to oversee submission-level documents and guide others towards shared goals within timelines and budgets.

• Understanding of effective communication practices.

• Strong time management and organizational skills.

• Ability to cultivate professional client relationships and keep abreast of current industry trends.

• Skill in identifying and institutionalizing effective work practices.

• Proficiency in resolving problems in sensitive or high-pressure environments.

• Ability to transfer knowledge and enhance organizational capabilities.

🏝️ Benefits

• Remote working opportunities.

• Flexible time off policies.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement program.

• Retirement plans.

• Eligible for bonuses.