Principal Medical Writer

🕒 il y a 9 jours

🇺🇸 États-Unis – Télétravail

💵 $95 000 - $175 700 / an

⏰ Temps Plein

🔴 Expert

🏥📝 Rédacteur Médical

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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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, including document strategy and cross-department coordination • Lead resolution of client comments • Prepare clinical study protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations • Follow ICH E3 guidelines, company SOPs, client standards, approved 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 an expert peer reviewer for the internal team • 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, 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; engage with industry groups • Monitor project budgets, contribute to bid projections, and communicate status and changes • Negotiate timelines and assigned deliverables • Represent medical writing on study teams, at conferences, meetings, and client presentations • Complete required administrative tasks and other assigned duties

🎯 Exigences

• Advanced degree in a scientific discipline required (MS, PhD, PharmD, MD, or equivalent) • PhD or PharmD strongly preferred • Minimum 5 years of relevant experience within the pharmaceutical, biotechnology, medical communications, or consulting industries • Demonstrated experience leading publication planning, publication strategy, and publication execution programs • Proven track record developing and executing integrated publication plans across multiple studies and assets • Strong hands-on scientific writing and content development experience, including manuscripts, congress abstracts, posters, and presentations • Experience utilizing AI tools and technologies to support publication development • Preferred location: U.S. East Coast • Minimal travel may be required (less than 25%)

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • 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) and sick time • Company car or car allowance may be included