Senior Medical Writer

4 weeks ago

United Kingdom Allergy Therapeutics Full time

About Us

Allergy Therapeutics are a market-leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.


We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Our vaccines are aluminium free. Driving convenience, our ultra-short course treatments make life easier and increase adherence.


Our adjuvant technologies not only advance the results of allergy immunotherapy but also drive beneficial immune responses in cancer and infectious disease.


We are a proud and passionate team with a vision that delivers growth and transforms the way we think about immunology.


We are continuing to grow and it’s an exciting time to be joining us. You will contribute to our ongoing success and be part of our future which is looking very bright


You’ll join a team of like-minded people who are passionate about what they do and providing positive outcomes for our patients.


We are looking for a Senior Medical Writer who will fulfil all medical writing needs for our R&D team.

About you


You will bring your experience in medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment to this role.

You will have experience of creating, managing, authoring and editing clinical protocols and/or other types of clinical documents (e.g., Informed Consent Form, Investigator Brochure, clinical parts of regulatory filing documents) as well as experience authoring CSR’s of Phase 1-3 studies.


We are looking for someone who is familiar with non-clinical and clinical trial methodology, statistical principles / concepts used in clinical research and experience in interpretation of statistical analysis and who has up-to-date knowledge of International Committee for Harmonisation/Good Clinical Practice/Regulatory requirements with an understanding of the basic strategy for regulatory submissions.


The role


You will be involved in the following:


  • Being the responsible author of clinical documents e.g., Investigator Brochure, Protocol, Clinical Study Report, Informed Consent Form and other supporting documents to support clinical development of an investigational medicinal product (IMP) and/or marketed products as required
  • Serve as an efficient and dedicated resource for the entire R&D, producing documents for diverse audiences
  • Developing and maintaining tracking of deliverables and timelines for the above-mentioned documents
  • Being responsible for the collation of data and driving contents of assigned clinical documents as applicable (e.g. Investigational Medicinal Product Dossier) and compilation of clinical sections of the Common Technical Document modules, including provision of responses to clinical queries such as Request for Information from the competent authorities, Institutional Review Board and/or Research Ethics Committees)
  • Working closely with the other members of R&D and wider company to develop, gather and synthesize input for the above-mentioned documents
  • Assisting in the writing of clinical abstracts, posters, and manuscripts
  • Developing and maintaining templates for Protocols, CSRs and other relevant clinical documents
  • Governing the R&D Department in accurate use of defined templates, use of the style guide, etiquettes of reviewing documents, etc
  • Delivering assigned Medical Writing objectives to ensure delivery of R&D programmes and documents delivered enabling submission of CTD standard dossiers
  • Efficient and effective communication and participation in project and study teams to acquire information for medical writing activities
  • Collaborating with cross functional teams to obtain the required information to timely deliver on medical writing tasks
  • Identifying processes to support efficient medical writing practice and improvements in document review process
  • Efficient cooperation with and oversight of external medical writing vendors


This is a remote role.

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