Job description
We are seeking an experienced Clinical Regulatory Writer / Documentation Specialist to support the development, coordination, and completion of critical clinical and regulatory documentation in a fully remote environment. This individual will play a key role in ensuring high-quality, accurate, and timely preparation of clinical reports, summary documents, package inserts, and other regulatory materials supporting product development and submissions.
This is an individual contributor role requiring strong technical writing expertise, attention to detail, and the ability to work independently with minimal supervision. The ideal candidate brings a solid understanding of clinical and pre-clinical documentation processes along with strong project coordination and timeline management skills.
Responsibilities
- Develop, edit, review, and finalize clinical and regulatory documents including:
- Clinical study reports
- Summary documents
- Package inserts
- Technical and scientific documentation
- Supporting regulatory submission materials
- Coordinate and support electronic regulatory submission activities as needed
- Ensure documents are accurate, compliant, and aligned with internal standards and regulatory requirements
- Provide recommendations for document formatting, templates, and documentation guidelines
- Offer guidance and direction to cross-functional teams regarding the development and completion of clinical and pre-clinical documents
- Manage document timelines and deliverables to ensure timely completion of projects
- Collaborate with clinical, regulatory, quality, and scientific stakeholders throughout the document lifecycle
- Review and analyze technical information to ensure clarity, consistency, and completeness
- Maintain strong attention to detail while balancing multiple priorities and deadlines
Qualifications
Required Qualifications
- Bachelor’s degree or equivalent combination of education and experience
- Minimum of 4 years of experience in clinical, regulatory, or technical writing within a regulated environment
- Experience developing clinical and/or pre-clinical documentation
- Strong understanding of regulatory documentation standards and processes
- Excellent written and verbal communication skills
- Ability to work independently and manage multiple projects simultaneously
- Strong organizational skills and attention to detail
- Experience managing timelines and coordinating document deliverables
Preferred Qualifications
- Experience supporting electronic regulatory submissions
- Familiarity with pharmaceutical, biotechnology, or medical device industries
- Knowledge of regulatory agency expectations and submission requirements
- Experience working in cross-functional clinical or regulatory teams
Additional Information
- Fully remote opportunity
- Individual contributor role with significant autonomy and ownership
- Fast-paced, collaborative environment supporting critical clinical and regulatory initiatives
