Senior Medical Writer – Sponsor-dedicated

🕒 il y a 4 jours

⏰ Temps Plein

🟠 Senior

🏥📝 Rédacteur Médical

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de Syneos Health, pas via un site d'emploi

Repérée par Remote Rocketship il y a 4 jours

Toujours ouverte sur le site de Syneos Health. Vérifiée il y a 1 heure.

Logo of Syneos Health

Syneos Health

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 • Manage medical writing activities for individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, regulatory submissions, journal 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 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 and data management, biostatistics, regulatory affairs, and medical affairs teams • Perform online clinical literature searches and comply with copyright requirements • Identify and resolve issues, provide technical support and training, and contribute to internal materials and process improvements • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Work within project budgets and communicate status and changes to medical writing leadership • Complete required administrative tasks and other assigned duties

🎯 Exigences

• 3-5 years of relevant experience in science, technical, or medical writing • Experience working in the biopharmaceutical, device, or contract research organization industry required • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required • Experience writing relevant document types required • 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

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Minimal travel may be required (less than 25%)

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