Principal Medical Writer – Publications

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

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This company has sponsored UK Skilled Worker visas in the past.

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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

• Lead the clear and accurate completion of complex medical writing deliverables • Manage medical writing activities for individual studies, including document strategy and cross-department coordination • Lead resolution of client comments • Complete clinical, regulatory, and publication documents including protocols, reports, submissions, manuscripts, abstracts, posters, and presentations • Ensure compliance with regulatory standards, company SOPs, client standards, templates, authorship requirements, and formatting guides • Advise clients and study teams on data presentation and production strategies • Lead team document reviews and review documents for technical issues • Coordinate quality and editorial reviews and manage source documentation • Serve as an expert peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Build relationships with clients and cross-functional teams • Perform online clinical literature searches and comply with copyright requirements • Identify and propose solutions, escalating issues as appropriate • Serve as a key technical subject matter expert and contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers • Develop expertise in industry topics and regulatory guidelines and engage with industry groups • Monitor project budgets and contribute to bid projections • Communicate status and changes, negotiate timelines and deliverables • Represent medical writing on study teams, conferences, meetings, and client presentations • Complete required administrative tasks and other assigned duties

🎯 Requirements

• Principal-level medical writing expertise • Experience completing complex medical writing deliverables with minimal supervision • Knowledge of regulatory standards, including ICH E3 guidelines • Ability to work with company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides • Experience with clinical study protocols and 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 • Ability to advise clients and study teams on data presentation and production strategies • Experience leading document reviews and coordinating quality and editorial reviews • Ability to review statistical analysis plans and table/figure/listing specifications • Experience collaborating with data management, biostatistics, regulatory affairs, medical affairs, clients, and study teams • Ability to perform online clinical literature searches and comply with copyright requirements • Ability to identify, propose, and escalate solutions to issues • Expertise in industry topics and regulatory requirements affecting medical writing • Ability to manage budgets, timelines, and deliverables • Ability to mentor and lead less experienced medical writers • Minimal travel may be required (less than 25%) • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Collaboration with diverse expert teams • Career paths and employment opportunities • Minimal travel (less than 25%)