Consultant I, Medical Writing

This is a fully remote position, open to applicants in United States.

📋 Description

• Create a range of regulatory documents, such as Clinical Study Reports (CSRs), study protocols, and materials for client submissions.

• Oversee the creation of intricate modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications).

• Implement quality control and submission-readiness procedures to produce high-quality documents within the agreed timelines set by clients.

• Act as the project owner by monitoring timelines, adjusting schedules, and collaborating with clients to meet changing requirements.

• Prepare for and foresee project challenges, update visual timelines, and ensure compliance with deadlines.

• Manage client interactions, including meetings, inquiries, and feedback sessions, while fostering and maintaining client trust.

• Guarantee consistency, accuracy, and alignment across documents in relation to client updates and relevant regulatory standards.

• Work with cross-functional teams to ensure the quality and precision of regulatory documents.

• Assist in the formulation of regulatory strategies for early-stage and smaller clients.

• Offer guidance on tools, document management systems, and client standard operating procedures (SOPs).

• Participate in continuous learning through exposure to new document types, processes, and industry best practices under the mentorship of senior staff.

⛳️ Requirements

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in a life or health science field is preferred.

• RAC certification is advantageous.

• A minimum of 3 years of industry experience.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project.

• Familiarity with regulatory document management systems, such as Veeva Vault.

• Experience with regulatory submissions and a solid understanding of global regulatory standards.

🏝️ Benefits

• Competitive base salary and annual incentive plan.

• Comprehensive benefits offerings.

• Ongoing recognition and opportunities for career development.

• Generous flexible paid time off program.

• Company-paid holidays.

• Flexible working hours.

• Fully remote or hybrid work options available for certain roles.