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Medical Writer
2 months ago
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. We're seeking a highly skilled Medical Writer to join our team and contribute to the development of high-quality clinical documents.
Key Responsibilities- Mentor and lead less experienced medical writers on complex projects, ensuring seamless collaboration and knowledge transfer.
- Act as lead for assigned writing projects, overseeing the development of clinical study protocols, reports, and other critical documents.
- Manage medical writing activities across departments, coordinating with data management, biostatistics, regulatory affairs, and medical affairs teams to deliver high-quality content.
- Develop and support a variety of documents, including clinical study protocols, reports, patient narratives, and regulatory submissions.
- Identify and propose solutions to resolve issues and questions arising during the writing process, ensuring timely and accurate delivery of documents.
- 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, ensuring alignment with company standards and client requirements.
- Serve as a 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, ensuring compliance and accuracy in medical writing.
- Work within budgeted hours and communicate changes to medical writing leadership, ensuring timely and cost-effective delivery of projects.
- 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 and expertise.
- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines, as well as familiarity with AMA style guide.
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills, ensuring a team-oriented approach.
- 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.
Syneos Health is a global biopharmaceutical solutions organization that has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We're committed to providing an environment and culture in which our people can thrive, develop, and advance. We offer valuable benefits, a quality-of-life balance, and opportunities for career growth and development.
The annual base salary for this position ranges from $60,930 to $115,100. We strongly encourage all employees to be fully vaccinated and maintain compliance with local government or customer requirements. Additional information may be provided upon request.
