Senior Medical Writer – Regulatory Focus

Emploi pas sur LinkedIn

🕒 il y a 3 jours

🌐 États-Unis, Canada – Distant

🇺🇸 États-Unis – Télétravail 🇨🇦 Canada – Télétravail

💵 $80 600 - $175 700 / an

⏰ Temps Plein

🟠 Senior

🏥📝 Rédacteur Médical

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Syneos Health

Site WebLinkedInTous les Emplois

10 000+ employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

Description

• Lead clear and accurate completion of medical writing deliverables and manage writing activities for individual studies • Coordinate medical writing activities across departments and lead resolution of client comments • Complete clinical, regulatory, safety, submission, and scientific meeting documents, including protocols, CSRs, IBs, patient narratives, aggregate reports, IND/NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations • Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides • Coordinate quality and editorial reviews, manage source documentation, and lead team document reviews • Act as peer reviewer for scientific content, clarity, consistency, and formatting • Review statistical analysis plans and table/figure/listing specifications and provide feedback on statistical outputs and document needs • Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams • Perform clinical literature searches and comply with copyright requirements • Identify and escalate issues and provide technical support, training, and consultation • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements affecting medical writing • Monitor assigned project budgets, communicate status and changes, and complete administrative tasks • Perform other assigned duties; minimal travel may be required (less than 25%)

🎯 Exigences

• 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, CSRs, IBs, patient narratives, briefing books, ISE, and ISS • Experience with Safety Aggregate Reports is a plus • Strong project management skills • Strong client experience • Strong time management skills • Process experience is a plus • Equivalent experience, skills, and/or education may be considered

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Company car or car allowance • Medical, dental, and vision health benefits • Company match 401(k) • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations when appropriate