FAQs
Is this position remote or hybrid?
This position is home-based, allowing for remote work in Portugal, Spain, France, Belgium, Germany, or Hungary.
What is the main responsibility of a Sr Regulatory Medical Writer?
The main responsibility is to manage medical writing activities for clinical studies, including the development of various regulatory documents such as clinical study protocols, reports, and submissions.
What qualifications are required for this role?
A Bachelor's degree in a relevant field with significant writing experience or a degree in Social Sciences, English, or Communications with scientific and/or medical knowledge is required.
How much experience is expected for this position?
The job posting does not specify an exact number of years of experience, but extensive knowledge of medical writing and regulatory guidelines is essential.
Are there opportunities for career development at Syneos Health?
Yes, Syneos Health is committed to the career development and progression of its employees through various training, supportive management, and recognition programs.
Will I need to travel for this position?
Minimal travel may be required for this role, estimated at less than 25%.
What types of documents will I be expected to write?
You will write a variety of documents, including clinical study protocols, clinical study reports, IND submissions, NDA submissions, and clinical journal manuscripts, among others.
Is familiarity with regulatory guidelines necessary for this position?
Yes, extensive knowledge of FDA and ICH regulations, as well as familiarity with the AMA style guide, is crucial for this role.
Will I be mentoring other writers?
Yes, as a Senior Medical Writer, you will have the opportunity to mentor and lead less experienced medical writers on complex projects.
How does Syneos Health promote a diverse and inclusive workplace?
Syneos Health is dedicated to creating an inclusive environment by bringing together diverse thoughts, backgrounds, cultures, and perspectives, ensuring that everyone feels they belong.