Parexel - Principal Medical Writer - UK / Ireland / Spain / Poland / Czech
This role can be based at either our Head Office situated in Uxbridge, Madrid, Dublin, Warsaw or Prague; or be fully home-based anywhere in the UK, Ireland, Spain, Poland or Czech Republic. As the Senior or Principal Medical Writer you will research, create, and edit all documents associated with clinical research. Responsibilities will also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.
- Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities.
- Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
- Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution.
Knowledge and experience
- Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
- Extensive clinical/scientific writing skills.
- Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
- Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring and file conversion and databases (Excel).
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
- Bachelor's degree in Life Sciences / Health related Sciences or equivalent.
- Excellent interpersonal, negotiation, verbal, and written communication skills.
- Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
- Motivation to work consistently in a fast-paced, rapidly changing environment.
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover
Are you ready for your Parexel Journey?
Are you ready to be part of a dynamic team that is making a difference in the lives of patients worldwide?