Preclinical Scientific Writer (Preclinical)

☞ Adaptimmune

View: 103

Update day: 01-06-2024

Location: Abingdon South East

Category: Science Labor Pharmaceutical / Chemical / Biotech

Industry: Pharmaceutical Biotechnology

Job type: Full-time

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Job content

ABOUT ADAPTIMMUNE
Adaptimmune is a leading clinical stage cell therapy company, designing and developing curative adoptive cell therapies for treating cancer. The Company’s unique SPEAR T-cell platform, engineers T-cells to target cancer antigens. With 3 wholly owned SPEAR T-cell products in clinical trials in multiple solid tumour indications, Adaptimmune is undergoing a period of expansion to increase our capabilities to deliver our novel therapies to patients with cancer.

In November 2020, we were recognised as a ’Great Place to Work’ both in the United Kingdom/United States (US). Our company culture is rooted in trust, our capacity to collaborate, being honest and brave in our desire to be successful in transforming the lives of people with cancer. It is this formula that enables us to face challenges and take advantage of opportunities in our fight against cancer.

ROLE OVERVIEW
Reporting to Group Leader, the purpose of this role is to primarily prepare preclinical writing deliverables across a wide range of projects, including documents for regulatory submission. The role will require a broad knowledge of cell biology and a proven ability to convey scientific information to enable collation and formulation of non-clinical data summaries, abstracts, posters and manuscripts. Secondarily, this role may additionally include performing Quality Assurance (QA) audits of data prepared for regulatory submission in support of clinical trial applications in US and Europe.

This role will involve liaising with other Research and non-Research functions and collaborating in cross-functional teams.

Performance in this role (including functional and project objectives and behaviours) will be monitored through group performance and stakeholder feedback from peers, senior management and project team members (as outlined in the development framework for this position).

KEY TASKS
  • Accountable for management, review, and delivery of assigned writing projects within established timelines.
  • Ensure all documents are authored according to regulatory requirements and internal standards.
  • Provide preclinical assistance in the preparation of documents for global regulatory submissions (e.g. clinical trial applications, IND applications).
  • Plan, perform and document internal QA audits of controlled studies and data intended for support of regulatory submissions.
  • Participate in group and project meetings and discussions.

QUALIFICATIONS & EXPERIENCE

Mandatory:
  • MSc or PhD in a relevant scientific area.
  • Substantial and relevant post-graduate exposure within an industry setting.
  • Proven record of writing scientific publications/papers.
  • Awareness of regulatory requirements for the conduct of nonclinical studies, including Good Laboratory Practices (GLP) and International Council for Harmonisation (ICH) guidelines.
  • Experience in evaluating data, summarizing reports, authoring, and reviewing documents to deliver high-quality documents within a reasonable time frame.
Additional/Nice To Have:
  • An in depth understanding of the relevant scientific area.
  • Examples of QA audits to GLP, including in study audits and final report audits.
  • Working in cross-functional project teams.
  • Previous experience in regulatory or clinical submissions.

SKILLS & COMPETENCIES

Mandatory:
  • Excellent attention to detail.
  • Excellent numeracy and English language skills (both written and verbal).
  • Excellent communication skills (both written and verbal).
  • Good organisational and time management skills, including ability to execute multiple projects in parallel, and prioritize tasks to meet deadlines.
  • Computer literate and ability to familiarise with different IT systems.
  • Strong team player but with the ability to also work autonomously as well.
Additional/Nice To Have:
  • Authoring tools (e.g. StartingPoint, PleaseReview, MasterControl), and document management software.
  • Work-stream leadership and planning.
  • Examples of people and project management.

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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Deadline: 16-07-2024

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