Sponsor Dedicated Protocol Medical Writer II

🔥 4 minutes ago

🌐 Canada, United States, +2 more countries – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 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.

📋 Description

• Partner closely with Clinical Scientists on protocols and protocol amendments • Lead clear and accurate medical writing deliverables • Manage medical writing activities for individual studies with minimal supervision • Coordinate medical writing activities within and across departments • Lead resolution of client comments • Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations • Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and act as an internal peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches and comply with copyright requirements • Identify and propose solutions, escalating issues as appropriate • Provide technical support, training, and consultation • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Monitor assigned project budgets and communicate status and changes • Complete required administrative tasks and other assigned duties

🎯 Requirements

• 3-5 years of relevant experience in medical writing, with proven experience in Protocol writing • Experience working in the biopharmaceutical, device, or contract research organization industry required • Experience with late development • Experience with Oncology/Hematology/Cell therapy • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required • Experience writing relevant document types required • Experience in working with Veeva/CARA • Extensive knowledge of English grammar and ability to communicate clearly • Strong familiarity with AMA Manual of Style • Equivalent experience, skills, and/or education will also be considered • Minimal travel may be required (less than 25%)

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Total Self culture • Diversity, inclusion, and belonging-focused workplace

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