
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
⢠Mentor less experienced medical writers on projects as necessary ⢠Compile, write, and edit medical writing deliverables with minimal supervision ⢠Develop or support clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures ⢠Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency ⢠Interact with data management, biostatistics, regulatory affairs, and medical affairs teams to produce writing deliverables ⢠Serve as a peer reviewer and address team comments for scientific content, clarity, consistency, and format ⢠Follow ICH-E3 guidelines, company SOPs, client standards, and approved templates while completing projects on time and on budget ⢠Perform online clinical literature searches as applicable ⢠Continue professional development related to regulatory guidance and client expectations ⢠Monitor project budget specifications and communicate changes to medical writing leadership ⢠Complete required administrative tasks and perform other assigned duties ⢠Travel minimally when required (less than 25%)
⢠Minimum 1 year of experience working in narratives with a master's qualification, or 2 years of experience with graduation ⢠Postgraduate (Masters / Mpharm) or bachelor's degree ⢠Good experience in drafting and reviewing narratives ⢠Extensive knowledge of English grammar, FDA and ICH regulations and guidelines, and familiarity with AMA style guide ⢠Effective presentation, proofreading, interpersonal, and leadership skills ⢠Strong proficiency in Word, Excel, PowerPoint, email, and Internet ⢠Familiarity with principles of clinical research ⢠Ability to interpret and present clinical data and other complex information ⢠Working knowledge of the drug development process and regulatory guidelines
⢠Career development and progression ⢠Supportive and engaged line management ⢠Technical and therapeutic area training ⢠Peer recognition ⢠Total rewards program ⢠Inclusive culture ⢠Minimal travel (less than 25%)
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