27 Jun Medical Writer
As a Medical Writer, you will be familiar with documents such as clinical study reports and the common technical document (CTD), and will be able to evaluate scientific data objectively, in order to report results and scientific concepts in a concise and accurate manner. In addition, you will work closely with the Clinical team and Regulatory Affairs Director to lead the planning and delivery of regulatory submissions and other projects.
Tasks & Responsibilities:
- Preparation, editing, formatting and finalisation of the following documents:
- Clinical documents; such as Protocol, Protocol Amendment, ICF, PIS, IB, CSR
- Regulatory documents; such as IND, NDA (ISS/ISE), Briefing documents
- Safety documents; such as DSUR, PSUR, ASR, Case Narratives
- Scientific Publications; such as Manuscripts, Abstracts, White Papers
- Manage medical writing timelines with functional area timelines for assigned documents to ensure on-time deliverables.
- Communicate with document authors, owners, contributors, and reviewers of different functional areas internally and externally to ensure appropriate coordination of and input into medical writing tasks.
- Facilitate comment resolution with authors, reviewers, and project teams.
- Participate in the development of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables.
- Assist in the interviewing, mentoring, and integration of new staff.
- Build and manage external relationships in support of these tasks as appropriate.
- Minimum of 3-5 years Medical Writing experience at a lead author level in the following; Clinical documents, Regulatory documents, Safety documents, Scientific publications.
- Strong scientific background including a minimum of a BSc (or equivalent) in an appropriate scientific discipline.
- Familiarity with EU regulatory guidelines for document development with respect to structure, format, and content. Having this experience in the US would be an advantage.
- Excellent writing skills with comprehensive knowledge of drug development process and applicable regulatory guidelines.
- Excellent written and spoken English, and a good working understanding of clinical development and ICH guidelines for regulatory documents.
- Proven track record of working on drug development programmes from pre-clinical and early phase clinical through to marketing application.
- Proactive, well-developed project management skills, and confident and effective interpersonal skills.
- Flexibility for occasional travel within Europe.
- A strong team player with the flexibility and the willingness to get involved with other activities that support the development of our drug programs.