A Regulatory Writer is required to join a regulatory affairs consultancy company based in Horsham, UK.
Reporting to the Operations Director of Regulatory Affairs, as a Regulatory Writer, your main responsibilities will include:
- Regulatory and medical writing activities in accordance with the project brief in a timely, accurate and efficient manner to the highest of standards.
- Attending project initiation meetings and taking project briefs.
- Liaising within freelancers and other external resources as required.
- Liaising with all team members to ensure timely QC and completion of all documents.
- Maintaining awareness of current practice in medical writing, medical information techniques and applicable regulatory guidelines.
Preparation of documents such as:
- Clinical Study reports
- Investigator brochures
- All components of CTD
- Clinical expert statements and case narratives.
- Single evaluation and issue workups.
- Benefit-Risk ration assessments.
The ideal candidate for this Regulatory Writer job will have the following skills and experience:
- Previous experience in medical / regulatory writing essential.
- Knowledge of the drug development process and applicable regulatory guidelines will be beneficial.
- Customer focused approach.
- Excellent written and oral communication skills.
- Good attention to detail.
- Ability to work ina team.
For more information or to apply for this Regulatory Writer job, please contact Meera Pattni on +44 (0)1438 743047 or email firstname.lastname@example.org.