Vaccitech - Medical Writer

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Vaccitech plc is a clinical stage biopharmaceutical company that spun out of The University of Oxford in 2016 and develops a range of immunotherapies and vaccines to tackle major diseases. The company has a headquarters near Oxford and also has a team and facilities in Maryland, USA.  We have an exciting new role as part of our continued growth.

The Medical Writer is responsible for providing scientific publications or regulatory document support and advanced scientific writing expertise to the global Vaccitech team, ensuring successful preparation of high quality submission-ready documents and effective management of the writing process.

  • Provides medical writing expertise for multiple products and/or projects.
  • Interfaces cross functionally to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. Key stakeholders being medical, clinical, manufacturing, programme management, research, immunology, regulatory affairs and QA.
  • Serves as the scientific writing content expert for the company.

Key responsibilities include:

  • Write, or have input into, documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical/non-clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
  • Coordinate quality control reviews of documents and maintaining audit trails of changes.
  • Provide input on data analysis planning and interpretation.
  • Serving as the primary contact for medical writing assignments, negotiating deliverable timelines and resolving project-related issues.
  • Liaison with, and management of, external medical writing consultants who are providing support to Vaccitech
  • Providing proactive support to project and programme leadership for planning efficient work plans and timelines for medical writing deliverables.

Essential Knowledge, experience and skills:

  • Degree in a life science field (PhD preferred)
  • Extensive medical writing experience within the clinical research field
  • Demonstrated understanding of the drug development process, and applicable regulatory guidelines
  • Preferably experience in a variety of indications, particularly infectious diseases and oncology
  • Experience with writing a variety of documents (Clinical Study Reports, Investigator Brochures, protocols/amendments, safety narratives, Developmental Safety Update Reports, scientific publications, briefing books,
  • Experience in early phase (I-¬‐II) studies and vaccine development
  • Excellent written and verbal communication and presentation skills
  • Excellent organisational and interpersonal skills
  • Ability to manage multiple priorities within one or across different projects
  • Excellent working knowledge of ICH GCP and current clinical trial legislation and current medical/scientific/manuscript writing guidance
  • Ability to work in a dynamic small team environment
  • Excellent interpersonal skills and problem solving/decision making skills
  • Highly proficient using MS Office programs, especially Word and Powerpoint

What we can offer you

  • Salary up to £70,000
  • Hybrid working
  • Discretionary annual bonus scheme
  • Stock options
  • 25 days holiday, increasing on length of service
  • AXA Healthcare plan
  • Life Insurance
  • Up to 5% pension contribution matched by the company

If you feel you have the skills and experience for this role then please send your cv with a covering email to tara.rist@vaccitech.co.uk.