Senior Medical Writer – Regulatory Focus

🔥 1 minute ago

🌐 Canada, United States, +1 more countries – Remote

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

⏰ Full Time

🟠 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

• Lead clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies and coordinate activities across departments • Lead resolution of client comments • Prepare 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 • Follow ICH E3 guidelines, standard operating procedures, 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 a peer reviewer • Review statistical analysis plans and table, figure, and listing specifications • Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams • Conduct online clinical literature searches and comply with copyright requirements • Identify and resolve issues, escalating as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Monitor project budgets, hours, status, and changes • Complete administrative tasks and other assigned duties

🎯 Requirements

• Minimum of 5 years of lead regulatory writing experience • Lead writing experience with Phase 2 and Phase 3 studies • Lead writer experience with protocols, submissions, CTD Modules 2.7.3 and 2.7.4, Clinical Study Reports, Investigator Brochures, Patient Narratives, Briefing Books, ISE, and ISS • Safety Aggregate Reports experience is a plus • Strong project management skills • Strong client experience • Strong time management skills • Process experience is a plus • Must be open to working remotely in the US, UK, or Canada • Equivalent experience, skills, and/or education may 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 • Minimal travel required (less than 25%)