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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 associated with individual studies, coordinating with departments and stakeholders to ensure timely delivery.
- Develop or 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 compliance with regulatory standards and company policies.
- Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency, ensuring high-quality deliverables.
- Interact with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
- 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, ensuring compliance and quality.
- Perform online clinical literature searches as applicable, staying up-to-date with industry practices and regulatory requirements.
- Maintain awareness of budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
- Complete required administrative tasks within specified timeframes, ensuring timely delivery of writing 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, with ability to demonstrate familiarity with principles of clinical research and interpret and present clinical data.
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, with a focus on quality-of-life balance and employee well-being.
The annual base salary for this position ranges from $60,930 to $115,100, with additional benefits including company car or car allowance, health benefits, company match 401k, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off (PTO) and sick time. Syneos Health has a voluntary COVID-19 vaccination policy, and certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees.
