Regulatory Medical Writer (Contract)
Location: Bay Area / RemoteType: Contract Position Summary:
We're seeking an experienced Regulatory Medical Writer to join our cutting-edge team at Peer AI, a pioneering GenAI-based medical writing company. As a contractor, you'll play a crucial role in crafting high-quality regulatory documents for our clients in the pharmaceutical, biotechnology, and medical device industries. With the potential to convert to a full-time employee (FTE) role, this opportunity offers a chance to be part of a revolutionary approach to medical writing.
Responsibilities:
Write and edit regulatory documents, including CSRs, Safety Narratives, BLAs, NDAs, INDs, and investigator brochures
Collaborate with cross-functional teams of medical writers, GenAI engineers client SMEs
Opportunity to help shape the product workflows and UI
Ensure compliance with relevant regulations, guidelines, and industry standards
Conduct literature searches and summarize complex scientific data
Develop and maintain templates, style guides, and standard operating procedures
Stay up-to-date with industry trends, best practices, and emerging technologies
Requirements:
Bachelor's degree in life sciences, English, or a related field
Minimum 3-5 years of experience as a regulatory medical writer
Proven portfolio of regulatory documents, including BLAs and NDAs
Strong understanding of FDA and ICH guidelines, regulations, and industry standards
Excellent writing, editing, and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Strong attention to detail, organization, and project management skills
Familiarity with AI-based tools and technology a plus
Nice to Have:
Advanced degree (MS, Ph.D.) in life sciences or a related field
Certification as a medical writer (e.g., AMWA, EMWA)
Experience with GenAI-based tools and platforms
Knowledge of data analytics and visualization
What We Offer:
Competitive hourly rate
Opportunity to work on innovative projects with cutting-edge AI technology
Collaborative and dynamic work environment
Flexible remote work arrangements
Potential to convert to a full-time employee (FTE) role
Professional development and training opportunities
How to Apply:
If you're a skilled and motivated regulatory medical writer looking for a new challenge, please submit your resume, cover letter, and portfolio to careers@getpeer.ai. We can't wait to hear from you!
About Peer AI:
Peer AI is a revolutionary GenAI-based medical writing company that harnesses the power of artificial intelligence to transform the life sciences regulatory writing process. Our team of experts is dedicated to delivering high-quality, compliant documents that meet the evolving needs of our clients. Join us in shaping the future of medical writing!