Principal Medical Writer – Publications

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $80 600 - $175 700 / an

⏰ Temps Plein

🔴 Expert

🏥📝 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 complex medical writing deliverables • Manage medical writing activities for individual studies, define document strategy, and coordinate activities across departments • Lead resolution of client comments • Complete clinical, regulatory, safety, publication, and scientific meeting documents, including protocols, clinical study reports, investigator brochures, informed consents, submissions, manuscripts, abstracts, posters, and presentations • Apply regulatory standards, company SOPs, client standards, templates, authorship requirements, and style guides • Advise clients and study teams on data presentation and production strategies • Lead document reviews and coordinate quality and editorial reviews • Serve as expert peer reviewer and review statistical analysis plans and table/figure/listing specifications • Build working relationships with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches and comply with copyright requirements • Identify and resolve issues, serve as a technical subject matter expert, and contribute to internal materials and process improvements • Mentor and lead less experienced medical writers • Develop expertise in industry topics and regulatory requirements and engage with industry groups • Monitor project budgets, contribute to bid projections, communicate status, and negotiate timelines • Represent medical writing on clinical study teams, at conferences, meetings, and client presentations • Complete administrative tasks and other assigned duties

🎯 Exigences

• Experience and deep expertise in medical writing and clinical study documentation • Ability to produce clear, accurate, and complex medical writing deliverables • Knowledge of ICH E3 guidelines and applicable regulatory requirements • Ability to follow SOPs, client standards, approved templates, authorship requirements, and style and formatting guides • Experience reviewing statistical analysis plans and table/figure/listing specifications • Ability to perform online clinical literature searches and comply with copyright requirements • Ability to advise clients and study teams on data presentation and production strategies • Ability to lead document, quality, editorial, and peer reviews • Ability to identify, propose, and escalate solutions to issues • Ability to mentor less experienced medical writers • Ability to manage budgets, timelines, and deliverables • Minimal travel may be required (less than 25%) • 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 • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • 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