Senior Medical Writer
hace 3 semanas
We are seeking a highly skilled Senior Medical Writer to join our team in Regulatory Affairs. As a key member of our clinical development team, you will be responsible for leading the development of high-quality clinical study protocols, reports, and other regulatory documents.
The ideal candidate will have a strong background in medical writing, with experience in regulatory affairs and clinical development. You will be responsible for mentoring and leading less experienced medical writers, as well as managing medical writing activities associated with individual studies.
Key Responsibilities:
- Develop and lead the development of clinical study protocols, reports, and other regulatory documents
- Mentor and lead less experienced medical writers on complex projects
- Manage medical writing activities associated with individual studies
- Collaborate with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs
- Adhere to established regulatory standards, including ICH-E3 guidelines, and Company Standard Operating Procedures
Requirements:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred)
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet
Why Syneos Health?
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
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