Senior Medical Writer

Location: Bay Area / Remote

Type: Full Time

Position Summary:

We are seeking an experienced Regulatory Medical Writer to join our cutting-edge team at Peer AI, a pioneering GenAI-based medical writing company. As a Senior Medical Writer at Peer, you will drive the fusion of medical writing expertise and cutting-edge GenAI technology to transform regulatory documentation. You will work closely with our clients to understand their needs, collaborate with our AI engineers to design prompt instructions and language for our Large Language Models (LLMs). You will help configure AI solutions to deliver tailored regulatory content.

Innovate with Our Team

In this role, you will inform product development, ensure regulatory alignment, and drive the adoption of AI-powered medical writing solutions. Join our team of innovators and transform the field with the power of GenAI.

Duties & Responsibilities:

Duties include but are not limited to:

AI-Driven Regulatory Documentation

• Design and develop high-quality regulatory documents using GenAI and automation software, ensuring accuracy and precision.

Partner with AI engineers to innovate and streamline regulatory writing processes

• Contribute insights and recommendations to shape AI-enabled product development, enhancing regulatory writing.

• Develop templates, style guidelines, and SOPs to standardize processes and ensure efficiency.

Collaboration

• With Clients: Build strong relationships with pharmaceutical clients, offering expert guidance and ensuring project success.

• With Project Team: Serve as a key communicator, keeping stakeholders informed of project updates and progress.

Thought Leadership and Strategy Contribution

• Stay up-to-date with regulatory guidelines and industry trends, maintaining expertise and thought leadership.

• Educate internal team members on medical writing best practices, processes and industry trends

• Contribute to company strategy discussions, providing perspective of medical writing

Requirements:

The following qualifications are preferred and/or equivalent applicable experience:

• Educational Background: University/college degree (life science or related allied health profession) and American Medical Writers Association Certification or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities. An advanced degree is preferred. 

• Experience: A minimum of 5-7 years of experience in regulatory medical writing, with a track record of producing high-quality clinical documents for pharma/biotech across the product life cycle.

• Regulatory Expertise: Comprehensive knowledge of regulatory guidelines and requirements, including ICH, FDA, and EMA, as well as a strong understanding of the drug development process.

• Technology Proficiency: Familiarity with AI-enabled services and automation tools is highly advantageous. Willingness to adapt to new technologies is essential.

• Communication Skills: Exceptional written and verbal communication skills, with the ability to effectively convey complex scientific and medical information.

• Client Focus: Strong interpersonal skills, enabling you to build and maintain client relationships and serve as a trusted advisor.

• Detail-Oriented: A keen eye for detail, ensuring document accuracy, completeness, and compliance.

• Team Player: A collaborative and adaptable mindset, suitable for a dynamic startup environment.

• Innovative Thinker: A forward-thinking approach, with a passion for exploring and implementing technological solutions in the regulatory medical writing process.

• Able to work independently, meet deadlines, demonstrate effective use of time, and handle multiple assignments simultaneously.

Capabilities: 

• Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed

• Ability to communicate in English (both verbal and written)

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:

• Very competitive salary and stock options

• Opportunity to work on innovative projects with cutting-edge AI technology

• Collaborative and dynamic work environment

• Flexible remote work arrangements

• 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!