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Regulatory Medical Writer
2 months ago
We are seeking a highly skilled Regulatory Medical Writer to join our team at Syneos Health. As a key member of our medical writing team, you will be responsible for creating high-quality clinical documents, including clinical study protocols, clinical study reports, and regulatory submissions.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects.
- Act as lead for assigned writing projects, ensuring timely and high-quality delivery.
- Develop and manage medical writing activities associated with individual studies, coordinating with cross-functional teams.
- Collaborate with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
- Review and revise documents to ensure accuracy, grammar, and consistency.
- Stay up-to-date with current industry practices and regulatory requirements, applying knowledge to ensure compliance.
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications) with relevant scientific and/or medical knowledge.
- Extensive knowledge of English grammar, FDA, and ICH regulations, and familiarity with AMA style guide.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data.
At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We offer a competitive salary range of $60,930 to $115,100, a company car or car allowance, health benefits, and a quality-of-life balance.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for medical writing, we encourage you to apply for this exciting opportunity.
