Medical Writer II – Clinical Trial Transparency

Emploi pas sur LinkedIn

🕒 il y a 5 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

🏥📝 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

• Mentors less experienced medical writers on projects, as necessary • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision • Develops or supports a variety of documents including clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs • Serves as peer reviewer on internal review team • Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format • Adheres to established regulatory standards and completes medical writing projects on-time and on-budget • Performs on-line clinical literature searches, as applicable • Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing • Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership • Completes required administrative tasks within the specified timeframes • Performs other work-related duties as assigned • Minimal travel may be required (less than 25%)

🎯 Exigences

• 1 to 3 years of experience in Disclosure • Knowledge of Clinical Research, Clinical Trial, clinical registries (CT.gov, CTIS- Clinical Trial information System, EUDRACT) • Experience in clinical registries, clinical trial Disclosure is mandatory • Experience in databases like Pharma CM/ Disclose • Good understanding of protocol registration process • Fine with combination of redaction Disclosure • Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred • Client interaction experience • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Total Self culture