Sponsor Dedicated Protocol Medical Writer II/Sr

🔥 12 hours ago

🌐 Spain, Portugal, +3 more countries – Remote

🇪🇸 Spain – Remote 🇵🇹 Portugal – Remote 🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 scientific meeting presentations • Adhere to ICH E3 guidelines, regulatory standards, SOPs, client standards, approved templates, authorship requirements, and style guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and act as a peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients, department heads, 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 • Contribute to internal materials, presentations, processes, standard practices, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Monitor project budgets and communicate status and changes to medical writing leadership • Complete administrative tasks and other assigned duties

🎯 Requirements

• 3-5 years of relevant experience in science, technical, or medical writing • Experience working in the biopharmaceutical, device, or contract research organization industry required • Experience with late development and Oncology/Hematology/Cell therapy/Neurology • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required • Experience writing relevant document types required • Experience working with Veeva/CARA • Extensive knowledge of English grammar and ability to communicate clearly • Strong familiarity with AMA Manual of Style • Ability to work remotely from Portugal, Spain, the UK, Poland, or Canada • 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 • Total rewards program • Inclusive culture • Minimal travel (less than 25%)