Medical Writer Project Director

About the job

About Us

In 2020, a group of senior technology and product experts from Google and Verily China decided to delve into the intelligent digitalization of life science clinical research. Their findings resulted in AlphaLife Sciences, a pioneer in the fusion of life sciences and AI computer science as an AI-enabled integrated clinical research platform. Our flagship product, AuroraPrime, integrates Generative AI and Large Language Models (LLMs) into a powerful AI-driven SaaS platform.

Trusted by global top MNCs, our innovations accelerate drug development and market entry. We are committed to globalizing AuroraPrime to enhance clinical trials and real-world research by leveraging cutting-edge AI, cloud computing, and big data. We help our clients achieve clinical operational efficiency, automate processes, and make smarter decisions to get their products to market faster.

We are proud partners with Microsoft's Pegasus Program, Google for Startups, and Johnson & Johnson Innovation JLABS, delivering cutting-edge solutions like Generative AI-Copiloted Medical Writing, Intelligent EDC and Data Management, and Agile Trial Management.

About the Role:

AlphaLife Sciences is looking for a Medical Writer Project Director to lead and coordinate our network of external medical writing consultants and to serve as the quality backstop for the documents they produce — including AI-generated drafts. This is a hands-on management role: you'll own the accuracy and consistency of a wide range of clinical and regulatory documents while acting as the internal domain expert who can review, refine, and elevate output across projects.

This role sits at the intersection of domain expertise, people management, and product. Beyond managing the consultant program day to day, you'll partner with our product team to give feedback on our internal AI tooling and help shape how we deliver medical writing services going forward.

Responsibilities:

• Manage a network of external medical writing consultants, coordinating assignments and ensuring high-quality, on-time delivery.

• Review and quality-check documents for accuracy at a high level, including proofreading and polishing AI-generated drafts, and suggesting AI templates for design.

• Maintain a broad, high-level overview across all document types produced by the team, spanning clinical and nonclinical documents, labeling, and CMC.

• Serve as the internal subject-matter anchor, sitting closer to the domain than anyone else on the internal team, and ramping into content as needed.

• Partner with clients and represent AlphaLife's work in client-facing settings.

• Work with the internal product team to provide feedback on our AI tooling, assess capabilities, and help identify solutions and features for the future.

• Assess consultant skill sets and help reshape and improve the consultant program over time.

• Contribute to longer-term service strategy as a thought partner to leadership.

First 30 / 60 / 90 Days:

• 30 days: Get familiar with our internal tooling, generate drafts, proofread and polish documents at a high level, and get up to speed on the consultant roster.

• 60 days: Engage directly with clients, begin giving internal feedback on the product, work with the product team, assess internal talent and skill sets, and begin reshaping the program.

• 90 days: Help define product strategy, act as a thought partner to leadership, and explore the company's service model.

Qualifications:

• Executive-level communication skills and comfort operating in ambiguity.

• Some hands-on people/team management experience (this is a working manager role, not purely strategic).

• Strong client relationship management experience.

• Bachelor's degree

• Genuine comfort with AI in the industry — someone who has already embraced AI in their everyday work and understands how it applies to regulated life-sciences workflows.

• Clinical operations, medical writing, or regulatory affairs experience in life sciences.

• Familiarity with pharma / clinical / regulated workflows (or the ability to ramp quickly).

• Existing relationships with pharma consultant networks.

• Early clinical background, with some regulatory knowledge helpful; ability to pick up other related document types.

AlphaLife Sciences is an equal opportunity employer and does not discriminate based on protected veteran status, disability, or other legally protected status. If you require a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please notify our recruiters at any stage of the process.

Please note: Applicants must be authorized to work in the United States without the need for current or future visa sponsorship. At this time, AlphaLife Sciences is unable to sponsor visas for applicants.