Preclinical Scientific Writer

Adaptimmune

Oxfordshire, GB
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 02/26/2021
  • Website: adaptimmune.com
  • Company Address: 351 Rouse Boulevard , Philadelphia, PA , 19112

About Adaptimmune

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Job Description

PRIMARY RESPONSIBILITY
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 understanding of cell biology and a proven ability to communicate scientific information to enable collation and formulation of non-clinical data summaries, abstracts, posters and manuscripts. Secondarily, this role may additionally include performing 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 RESPONSIBILITIES
• Accountable for management, review, and delivery of assigned writing projects within agreed timelines.
• Ensure all documents are authored according to regulatory requirements, and internal standards.
• Provide preclinical support 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

Required
• MSc or PhD in a relevant scientific area.
• Substantial and relevant post-graduate experience 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 ICH guidelines.
• Experience in evaluating data, summarizing reports, authoring, and reviewing documents to deliver high-quality documents within a reasonable time frame.

Desirable 
• An in depth understanding of the relevant scientific area.
• Experience with QA audits to GLP, including in study audits and final report audits.
• Experience working in cross-functional project teams.
• Previous experience in regulatory or clinical submissions

SKILLS & COMPETENCIES

Required
• 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 work independently as well.

Desirable
• Experience using authoring tools (e.g. StartingPoint, PleaseReview, MasterControl), and document management software.
• Work-stream leadership and planning experience.
• Exposure and some experience with 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.

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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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.