FAQs
What is the job title for this position?
The job title is Senior Regulatory Medical Writer.
Where is this job located?
This position is home-based and available in Portugal, Spain, France, Belgium, Germany, and Hungary.
What is the primary responsibility of a Senior Regulatory Medical Writer at Syneos Health?
The primary responsibility includes managing medical writing activities associated with clinical studies and developing various types of clinical documents.
What kind of documents will I be responsible for writing?
You will be responsible for writing clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, NDA submissions, investigator brochures, and more.
What qualifications are required for this position?
A Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications, along with relevant scientific and/or medical knowledge is required.
Is there a requirement for prior experience?
Yes, extensive knowledge of English grammar, FDA and ICH regulations, and experience in medical writing are necessary for this role.
Will I need to travel for this job?
Minimal travel may be required, estimated to be less than 25%.
What skills are essential for this position?
Essential skills include effective presentation, proofreading, interpersonal and leadership skills, as well as strong proficiency in Word, Excel, PowerPoint, and internet tools.
Is there an emphasis on teamwork in this role?
Yes, a team-oriented approach is important, and mentoring less experienced medical writers is a responsibility of this position.
What is Syneos Health's commitment to employee development?
Syneos Health is passionate about developing its people through career development opportunities, supportive management, training, and a recognition program.
What is the company's stance on diversity and inclusion?
Syneos Health is committed to creating a diverse and inclusive workplace where everyone feels they belong, by valuing diverse thoughts, backgrounds, cultures, and perspectives.
Are there specific regulatory standards I need to adhere to?
Yes, you need to adhere to established regulatory standards, including ICH-E3 guidelines, company SOPs, and client standards during medical writing projects.
Will my prior experience be considered even if it doesn't exactly match the qualifications?
Yes, equivalent experience, skills, and education will be considered, as the company has the discretion to determine qualifications.