Principal Medical Writer – Clinical Focus

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

📋 Description

• Create high-quality documentation for regulatory submissions to enhance the regulatory documentation process for clients.

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

• Manage projects and serve as an author for all types of client engagements.

• Guide and mentor others in the creation of regulatory documents.

• Oversee submission-level sections for clinical documents, including Clinical Study Reports, Protocols, Investigator Brochures, ISS, and ISE.

• Lead sub-teams focused on pharmacovigilance and transparency and disclosure deliverables.

• Assume responsibility for clarity of objectives and direct others towards shared goals within timelines and budgets on intricate projects.

• Handle crisis communications and manage associated risks.

• Identify and swiftly resolve potential issues, especially in sensitive or high-pressure situations.

• Leverage expertise across various therapeutic areas to achieve business successes and disseminate knowledge throughout the organization.

⛳️ Requirements

• Minimum of a Bachelor's degree.

• Over 7 years of experience in regulatory writing, particularly with clinical-related documentation.

• Familiarity with regulatory requirements across different development phases and various regulatory pathways.

• Knowledge of global health authority regulations.

• Proven experience in writing and managing a variety of documents in full, including study and submission level and pharmacovigilance documents.

• Strong comprehension of the document creation process and the drug development lifecycle.

• Intermediate proficiency in Microsoft Word, including editing tools, table creation, and figure insertion.

• Experience with document management techniques.

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

• Capability to lead submission-level sections, encompassing Clinical Study Reports, Protocols, Investigator Brochures, ISS, and ISE.

• Ability to guide sub-teams responsible for deliverables, including pharmacovigilance documents and transparency and disclosure outcomes.

• Understanding of best practices in communication.

• Extensive experience and technical knowledge across multiple therapeutic areas.

• Proficient in conveying complex and challenging ideas clearly and effectively to all stakeholders.

🏝️ Benefits

• Remote working opportunities.

• Flexible time off policy.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement program.

• Retirement plans available.

• Eligibility for bonuses.