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 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!