Principal Regulatory Writer – Temporary

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

📋 Description

• Develop precise, compliant, and informative documents necessary for regulatory submissions to global health authorities such as the FDA and EMA.

• Compose and revise a diverse array of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, internal/external labeling documents (e.g., CCDS/CCSI, annotated draft labels, IFU, patient leaflets), and components of regulatory submission dossiers (e.g., NDA, IND, MAA) such as Module 2 and 5 summary documents (e.g., SCS, SCE, ISS, etc.).

• Ensure that all written materials strictly comply with regulatory guidelines, industry standards, and internal quality benchmarks.

• Evaluate intricate scientific and medical information, including clinical trial data, converting it into clear, concise, and accurate language that is understandable by both technical and non-technical audiences.

• Collaborate closely with cross-functional teams (e.g., clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc.) to guarantee comprehensive and precise document content.

• Oversee medical writing projects, including establishing timelines (in collaboration with study/project teams, as needed) and communicating with cross-functional team members to keep them informed about review cycles and expectations.

• Engage in cross-functional meetings to contribute insights regarding medical writing deliverables, timelines, and any processes necessary for completing regulatory documents.

• Assist in defining and drafting standard operating procedures and best practices for the efficient preparation of high-quality documents.

• Offer guidance to teams about best practices and industry standards, address authoring challenges, and facilitate interaction and understanding across functional areas.

⛳️ Requirements

• A Bachelor’s degree along with 15 to 20 years of relevant experience is required. An advanced degree in a scientific or medical field is advantageous.

• Experience with all standard study-level and submission-level regulatory documents such as CSRs, IBs, DSURs, protocols, and eCTD modules is mandatory.

• Demonstrated experience with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), including responses to health authorities, 90/120-day safety updates, or other post-submission activities is essential.

• Expert knowledge of eCTD structure and the clinical development process, along with in-depth understanding of document-related ICH guidelines and GxPs is necessary.

• Proven ability to manage complex projects and influence cross-functional teams is required.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and continuing education.

• Flexible work arrangements to support work-life balance.

• Collaborative and innovative work environment.