Medical Writer

Ellipses Pharma is a global drug development company headquartered in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group, which comprises more than 300 leading oncologists and an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.

The Role

Ellipses, driven by a robust pipeline of strong clinical candidates, is at an exciting stage of its evolution that promises business growth and the swift delivery of innovative medicines to patients. As part of this transformation, we are seeking a highly motivated and experienced Medical Writer professional to join our team.

The Medical Writer will be responsible for the creation, review, and editing of high-quality regulatory and scientific documents to support the development of our asset pipeline. This role will report into the Senior Clinical Scientist and work closely with Clinical Operations, Asset Leaders, and Head of Clinical Strategy.

Our pipeline currently consists of four phase 2 assets and 2 pre-clinical assets.

We are looking for someone with strong end to end protocol development experience within early phase oncology, together with an ability to communicate effectively across all levels.

Key Responsibilities

• Lead the development and review of early-stage clinical study protocols and amendments, ensuring cross-functional collaboration to deliver a scientifically robust, regulatory compliant and operationally feasible protocol according to the agreed development strategy.
• Lead the development and update of Investigator’s Brochures in collaboration with key SMEs.
• Author/review relevant components of regulatory submissions and responses eg IND or equivalent, annual reports (including DSURs), briefing documents.
• Author/review other key clinical study documents and reports eg Patient Information Sheets, Statistical Analysis Plans, Clinical Study Reports.
• Maintain a high level of knowledge of regulatory requirements and standards for early-stage clinical study design.
• Conduct literature evaluations to source reference materials and understand competitive landscape.
• Coordinate external vendor and KOL/SME support for key clinical and regulatory documentation, as required.
• Ensure a high level of Good Documentation Practice including QC, traceability, version control and filing.
• Lead to the development and implementation of processes and templates to support efficient and consistent production of key clinical trial documents.
  
  

Experience, Skills & Knowledge

• A degree in a Life Sciences or related field.
• At least 5 years’ experience in relevant clinical research or scientific roles within a biotech, pharmaceutical or Contract Research Organisation environment
• A solid understanding of Good Clinical Practice (GCP), clinical research and statistical methodologies, and regulatory guidelines and processes.
• Proven track record in the development of, writing, and delivery of study protocols, amendments and ancillary regulatory documents required to conduct and report global Phase 1 and 2 trials in oncology.
• Experience in multiple drug modalities and oncology indications preferred.
• Strong attention to detail, with the ability to proofread and edit documents for scientific accuracy, grammar, and clarity.
• Ability to manage multiple projects simultaneously, adapt quickly to change, work under pressure and to tight deadlines
  
  

Personal Attributes

• Pragmatic, solution focussed and willing/able to roll up sleeves in a fast-moving, small company environment and contribute across the business in addition to their main area of focus.
• Passionate about delivery of high-quality documentation with clear communication style and a passion for helping advance the development of innovative oncology therapeutics
• Must be highly organised with a methodical approach to work
• Self-motivated taking personal pride in delivering on personal and corporate objectives
• Experience working effectively in a team/matrix environment but also able to work independently and without supervision.
  
  

Ellipses Pharma is an organisation that values the strength of collaboration, inclusive and quick decision making, knowledge sharing and a culture built on working together on site. As a small but growing company face to face interaction is highly valued.

We recognise that a more hybrid approach is at times required and we do support some element of remote working where operationally appropriate to help employees with work life integration.

By balancing in-person presence with occasional remote working, we ensure we remain agile while protecting the unique benefits that come from working side by side.