Regulatory Medical Writer (Contract)
peer aiMillbrae, CA
Regulatory Medical Writer (Contract)
peer aiMillbrae, CASenior L5
Electromedical and Electrotherapeutic Apparatus ManufacturingResearch and Development in BiotechnologyOther Scientific and Technical Consulting Services
APPLY NOW (opens in a new tab)Regulatory Medical Writer (Contract) Contract, Remote
Location: Bay Area / Remote
Type: Full Time
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 SMEsOpportunity to help shape the product workflows and UIEnsure 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 NDAsStrong 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!
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Level
Senior L5
Location
Millbrae, CA
Occupation
Regulatory Affairs Specialists
Industry
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Posted
yesterday