Senior Medical Writer, Publications

🔥 il y a 22 heures

🇺🇸 États-Unis – Télétravail

💵 $80 600 - $175 700 / an

⏰ Temps Plein

🟠 Senior

🏥📝 Rédacteur Médical

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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 medical writing deliverables • Manage medical writing activities for individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical study protocols, protocol 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 scientific meeting presentations • Adhere to regulatory standards, SOPs, 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 an internal peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches • Identify and propose solutions, escalating issues as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standard practices, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Monitor project budgets and communicate status and changes to medical writing leadership • Complete administrative tasks and other assigned duties • Travel minimally, if required

🎯 Exigences

• Experience and deep expertise in medical writing and clinical research documentation • Ability to lead medical writing deliverables with minimal supervision • Knowledge of ICH E3 guidelines, regulatory standards, SOPs, client standards, templates, authorship requirements, and style and formatting guides • Ability to coordinate quality and editorial reviews • Ability to review statistical analysis plans and table/figure/listing specifications • Ability to perform online clinical literature searches and comply with copyright requirements • Ability to identify and resolve issues and provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers • Deep expertise in relevant industry topics and regulatory requirements and guidelines • Ability to work within budgeted hours and communicate status and changes • 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 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