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Regulatory Medical Content Specialist
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 clinical development team, you will be responsible for creating high-quality medical writing deliverables that meet regulatory standards.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects.
- Act as lead for assigned writing projects, managing medical writing activities and coordinating with departments.
- Develop and support a variety of documents, including clinical study protocols, reports, and submissions.
- Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Interact with department heads and staff members to produce writing deliverables.
- Serve as peer reviewer on internal review teams, providing review comments on draft and final documents.
- Adhere to established regulatory standards, including ICH-E3 guidelines and Company Standard Operating Procedures.
- Maintain familiarity with current industry practices and regulatory requirements.
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- 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.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
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, a 401(k) plan, and eligibility to participate in an Employee Stock Purchase Plan. We also offer flexible paid time off (PTO) and sick time, as well as opportunities for professional growth and development.
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced medical writer looking for a new challenge, please submit your application.
