Regulatory Writer at Weave

The Opportunity

At Weave we are are accelerating therapeutics’ journey to the market to the speed of AI, beginning with INDs.

We are seeking an experienced and adventurous Medical Writer to join our Customer Success team, reporting to our Chief Product Officer. This is anything but your traditional medical writing role. We are building an AI-powered platform, called AutoIND, to automate and streamline all aspects the preparation of regulatory filings, and we need your help to do so! Our platform drafts regulatory filings for our customers, but they still often require a human touch to take them the final mile. We are also continually and iteratively refining our content generation systems, and the feedback of expert humans is an essential ingredient in that process. You will address both of these needs as part of a customer-obsessed, savvy, and deeply passionate team.

Core Responsibilities

• Collaboration: You’ll be joining teams building products and serving customers, and you’ll play a vital role in both. But it’s one role among many, all of which must harmonize to produce a melody. First and foremost you’ll be a member of a diverse team that trusts and relies upon you, and thrives on effective communication.
• White glove service: You will help our customers go the last mile in the preparation of their regulatory filings, picking up where AutoIND leaves off. You will do the writing and editing that the AI couldn’t to ensure our customers are left with no gap between them and submission.
• Hone our platform: You know scientific writing and you know what our customers have been through. You’ll bring all of this knowledge to bear by aiding our product teams in the continued development of our platform. Your annotation of our AI-generated content and feedback on the elements of excellent scientific writing will be pivotal in the evolution of ever-better content generation.
• Sales support: You will support the Sales team in winning new business by advising on writing-related questions, speaking with prospects, and aiding proposal generation.
• Sustain the business: In everything you do you’ll ensure that the business not only survives but thrives. You’ll strive to be lean in building and rich in outcomes.

Ideal Candidate Profile

• Deep writing experience in INDs: You’ve made pivotal contributions to multiple successful IND submissions, ideally across companies, therapeutic areas, and/or modalities. In a perfect world your experience spans non-clinical and CMC content.
• Tech forward: You’re comfortable with SaaS tools, you know what an LLM is (not necessarily how it works), and you enjoy using new tools/software because it helps you to be efficient. You relish figuring out how to most effectively incorporate software into your workflows.
• Pragmatic strategist: You think before you do, considering the various ways to get from A to B and then choosing the path that best optimizes for your goals and constraints. But you don’t think too long, and you refuse to let perfect get in the way of achieving the goal.
• Independent team player: You get why this isn’t an oxymoron. You think and then you do. You start on your own and you don’t get stuck in the endless possible variations. You can chart your own course as needed to achieve your goals, and you never forget to bring your team along with you.
• Customer-obsessed communicator: You’ve worked with customers and loved it. You gain deep satisfaction from helping people to achieve their aims and appreciate the vital role that effective communication plays in getting there.

Qualifications

• 7+ years experience in medical, technical, or scientific writing
• Substantive hands-on contributions to multiple successful initial IND submissions, whether at therapeutics companies or consultants (CROs, CDMOs)
• Deep experience in one of: non-clinical, CMC, or clinical writing. Conversant in the others.
• Advanced degree required, PhD in life sciences preferred