ESPL are seeking a Regulatory/Medical Writer, based in Ireland or the UK, to join the team and work alongside the Senior Management Team and Consultants in supporting the document writing activities of the ESPL team.
This permanent role will include:
- Preparation of documents to support regulatory activities at various stages of pharmaceutical or medical device development, such as :
- Clinical Summaries and Overviews
- Risk Management Plans
- Scientific Advice briefing documents, PIPs, Orphan Designations
- SmPCs and package leaflet
- Working with the ESPL team and external contracting consultants to:
- Support activities of more junior regulatory and administration staff on specific projects
- Liaising with clients in collation, review and delivery of regulatory documentation
- Working with the ESPL Board to help:
- Explore and develop new work opportunities for the business
- Develop and implement initiatives to train and strengthen the regulatory knowledge of the ESPL Team
SKILLS REQUIRED
- Strong command of the English language and clear communication in various written formats and face to face
- Ability to present complex information in a logical way
- A perfectionist’s attention to detail, ensuring that the content, format and structure of their documents comply with regulatory, journal, or other guidelines
- Project-management skills and a proven ability to meet deadlines
If you are interested, or curious to know more, please contact/send your CV to us