Senior Medical Writer – Regulatory & Clinical Documentation
Job Title : Clinical Regulatory Writer
Location : Remote
Pay range : $40 - $45
Duration : 12+ MONTHS
We are seeking an experienced and detail-oriented Clinical Regulatory Writer / Clinical Documentation Specialist to support the development, review, and management of clinical and regulatory documentation within a highly regulated healthcare environment. This role will be responsible for preparing clinical reports, summary documents, package inserts, and other technical documentation while ensuring accuracy, consistency, and compliance with internal and regulatory standards.
The ideal candidate will have strong technical writing experience within medical device, pharmaceutical, biotechnology, or healthcare industries and be comfortable working independently in a fast-paced, deadline-driven environment.
This is a fully remote individual contributor role requiring strong organizational skills, attention to detail, and the ability to manage multiple documentation projects simultaneously.
Key Responsibilities
• Develop, review, edit, and finalize clinical reports, technical summaries, package inserts, and regulatory documentation
• Support electronic regulatory submission processes and ensure submission readiness
• Coordinate timelines and deliverables for clinical and pre-clinical documentation projects
• Ensure documentation aligns with company standards, regulatory guidelines, and formatting requirements
• Provide recommendations for documentation templates, formatting standards, and process improvements
• Collaborate cross-functionally with Clinical, Regulatory Affairs, Quality, Medical Writing, and R&D teams
• Maintain accurate documentation records and version control processes
• Manage multiple concurrent projects while meeting strict deadlines
• Independently resolve documentation-related issues using professional judgement and technical expertise
Qualifications
• Bachelor’s degree or equivalent experience required
• 4+ years of experience in clinical writing, regulatory writing, medical writing, or technical documentation within a regulated environment
• Experience supporting clinical or regulatory submissions preferred
• Strong understanding of medical device, pharmaceutical, biotech, or healthcare documentation standards
• Excellent written communication, editing, and organizational skills
• Ability to work independently with minimal supervision
• Experience with electronic submission systems and document management tools preferred
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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Location : Remote
Pay range : $40 - $45
Duration : 12+ MONTHS
We are seeking an experienced and detail-oriented Clinical Regulatory Writer / Clinical Documentation Specialist to support the development, review, and management of clinical and regulatory documentation within a highly regulated healthcare environment. This role will be responsible for preparing clinical reports, summary documents, package inserts, and other technical documentation while ensuring accuracy, consistency, and compliance with internal and regulatory standards.
The ideal candidate will have strong technical writing experience within medical device, pharmaceutical, biotechnology, or healthcare industries and be comfortable working independently in a fast-paced, deadline-driven environment.
This is a fully remote individual contributor role requiring strong organizational skills, attention to detail, and the ability to manage multiple documentation projects simultaneously.
Key Responsibilities
• Develop, review, edit, and finalize clinical reports, technical summaries, package inserts, and regulatory documentation
• Support electronic regulatory submission processes and ensure submission readiness
• Coordinate timelines and deliverables for clinical and pre-clinical documentation projects
• Ensure documentation aligns with company standards, regulatory guidelines, and formatting requirements
• Provide recommendations for documentation templates, formatting standards, and process improvements
• Collaborate cross-functionally with Clinical, Regulatory Affairs, Quality, Medical Writing, and R&D teams
• Maintain accurate documentation records and version control processes
• Manage multiple concurrent projects while meeting strict deadlines
• Independently resolve documentation-related issues using professional judgement and technical expertise
Qualifications
• Bachelor’s degree or equivalent experience required
• 4+ years of experience in clinical writing, regulatory writing, medical writing, or technical documentation within a regulated environment
• Experience supporting clinical or regulatory submissions preferred
• Strong understanding of medical device, pharmaceutical, biotech, or healthcare documentation standards
• Excellent written communication, editing, and organizational skills
• Ability to work independently with minimal supervision
• Experience with electronic submission systems and document management tools preferred
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Apply tot his job
Apply To this Job