Medical Regulatory Writer

Healx; Cambridge; Hybrid; GBP 35,000 - 65,000; Full time

Job description

About Healx

There are 10,000 known rare diseases that affect 400 million people across the globe, and 95% of them have no approved treatment. We’re on a mission to change that.

We are pioneering the next generation of drug discovery by applying frontier AI technology to accelerate the pace, increase the scale and improve the chance of success of rare disease treatment development in order to meet this huge unmet need and have unprecedented patient impact.

Diversity and inclusion sits at the heart of our mission to help people with rare diseases, and we believe that attracting and empowering a diverse team is critical to achieving this goal. We welcome applications from people from all backgrounds and walks of life.

Below we have included the qualities that we feel are required for you to excel in this role; however we appreciate that people can apply transferable skills from all walks of life and experience. If you think you have what it takes, love our mission and resonate with our values but are worried you don't tick every box - we still want to hear from you and encourage you to apply!

The Role

The Medical Regulatory Writer plays a key role in advancing drug development by creating high-quality, accurate, and compliant documentation essential for regulatory submissions. They will have a deep understanding of the drug development process, from early clinical trials through to post-marketing surveillance. This role is integral to translating complex scientific and clinical data into clear, accessible narratives for a variety of audiences, contributing to strategic decision-making and helping bring new treatments to rare disease patients. This role will also interact with and participate in communications functions for other parts of the company.

The Team

Working as part of our Clinical Team, this role works closely with cross-functional teams, including clinicians, scientists and regulatory affairs professionals to ensure critical information is communicated effectively to diverse audiences.

You’ll be:

1. Authoring Clinical Documents
   • Authoring clinical documents, including protocols, amendments, and briefing documents
   • Preparing regulatory and clinical documents such as IND annual reports/DSURs, Investigator’s Brochures, informed consent forms, and clinical study reports (CSRs), ensuring compliance with GCP, ICH, and other regulatory guidelines
   • Lead document review workstreams, coordinating with project teams ensuring timely, high-quality delivery
2. Data Review and Interpretation
   • Collate, review and interpret clinical data (adverse events, efficacy, PK/PD)
   • Leading document review workstreams, coordinating with cross-functional teams to ensure timely, high-quality delivery
3. Strategic Input and Collaboration
   • Support development of study planning, including SAPs and safety management plan
   • Collaborating with the project team to evaluate clinical data and contribute to the design of clinical development strategies and study concepts
   • Co-author company materials, including press releases, website content and social media
4. Publication and Communication
   • Supporting internal reviews for scientific journal submissions and shaping the publication strategy
   • Writing abstracts, presentations, manuscripts, and grant applications to support scientific and business objectives
5. Process Optimisation
   • Enhance internal workflows by contributing to the development of best practices, Standard Operating Procedures (SOPs), and document templates
   • Ensure all written materials adhere to company branding, regulatory requirements, and industry standards
6. Project Management
   • Coordinate document reviews, managing multiple deliverables across various stages of development
7. Regulatory Submissions
   • Prepare submission materials for various stakeholders, including health authorities, review boards, and ethics committees

We’re looking for someone who has:

• Bachelors degree in life sciences, pharmacy, healthcare or a related discipline
• 4+ years of Medical writing experience within a clinical research setting
• Previous experience in a similar role within a pharmaceutical, biotech or CRO environment
• Ideally possesses oncology or rare disease experience in a clinical scientist or medical writing role
• Proven ability to write a range of clinical trial documents, including protocols, informed consent forms, regulatory submissions (IND sections, CSRs, Investigator’s Brochures) and scientific publications/ presentations

It’s a bonus if you have:

• A PhD in life sciences, pharmacy or a related field
• Strong written communication skills outside of the clinical realm

Our Values:

• Care for Rare - Rare disease patients are at the heart of what we do
• Grow as individuals - We are learners always seeking to enhance our expertise
• Win as a team - We strive to remain inclusive and diverse and we celebrate successes and lessons together
• Innovate and deliver - Our mission requires rapid innovation and calculated risks that won’t compromise our high standards

Technologies we use: Slack, GSuite, Google Meet, Confluence, Zoom, BambooHR, Xero, ApprovalMax, Dext, Culture Amp

What's on offer:

1. Financial: Competitive salary, share options, 7% employer pension contributions, life insurance of 4x base salary
2. Health and Wellbeing: Private medical insurance, 25 days annual leave (plus bank holidays) with the option to purchase additional days to support a healthy work-life balance, wellbeing support via Spill and our Employee Assistance Programme
3. Hybrid Working: Flexible and remote working options, home office set-up allowance, periodic in-person team days for company-wide collaboration and celebration
4. Family Friendly: Enhanced family leave policies including leave for reproductive health, flexible working practices to balance personal and professional life
5. Personal Development and Growth: Personal learning and development budgets, regular personal development conversations and career support
6. Community Engagement and Support: One paid day off per year to volunteer for a cause aligned with our mission of supporting patients living with rare diseases; the opportunity to hear from and engage with patient groups and communities who offer us valuable insights into the experiences of those affected by rare diseases

For more information about Healx and how we use your data please go to https://healx.ai/privacy/