Strategic Medical Content Specialist
3 days ago
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
About the Role
We are seeking a highly skilled Strategic Medical Content Specialist to join our team. This role will be responsible for mentoring and leading less experienced medical writers on complex projects, as necessary. The ideal candidate will have extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. They will also have strong proficiency in Word, Excel, PowerPoint, email, and Internet, and ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Responsibilities
The successful candidate will manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. They will develop or support a variety of documents, including clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, as well as clinical journal manuscripts, clinical journal abstracts, and client presentations. The candidate will identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. They will review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Additionally, they will interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Qualifications
The ideal candidate will have a 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. They will have demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. A strong proficiency in Word, Excel, PowerPoint, email, and Internet is required, as well as ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Benefits
At Syneos Health, we offer a comprehensive benefits package that includes health insurance, 401(k) matching, employee stock purchase plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Our salary range for this position is between $60,930 to $115,100 per year, depending on qualifications and experience.
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