Senior Medical Writer – Regulatory

🕒 vor 4 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $80.600 - $175.700 / Jahr

⏰ Vollzeit

🟠 Senior

🏥📝 Medizinischer Autor

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Syneos Health

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10.000+ Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Syneos Health ist eine führende, vollständig integrierte biopharmazeutische Lösungsorganisation, die darauf ausgelegt ist, den Erfolg ihrer Kunden zu beschleunigen. Sie übersetzen einzigartige klinische, medizinische und kommerzielle Erkenntnisse in Ergebnisse, um den Anforderungen des modernen Marktes gerecht zu werden. Durch die Nutzung fortschrittlicher Technologien und Erkenntnisse arbeitet Syneos Health mit Kunden zusammen, um die Bereitstellung wichtiger Therapien für Patienten weltweit zu beschleunigen, und bietet Dienstleistungen, die das gesamte Spektrum von der klinischen Entwicklung bis zur Kommerzialisierung abdecken.

Beschreibung

• Lead clear and accurate completion of medical writing deliverables and coordinate activities within and across departments. • Complete clinical and regulatory documents, including protocols, clinical study reports, patient narratives, investigator brochures, informed consents, safety reports, development plans, IND submissions, integrated summaries, NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations. • Adhere to ICH E3 guidelines, company and client standards, templates, authorship requirements, and style guides while delivering on time and on budget. • Coordinate quality and editorial reviews, manage source documentation, lead team document reviews, and perform peer reviews. • Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. • Build working relationships 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, training, and consultation, 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 affecting medical writing. • Monitor project budgets, communicate status and changes to medical writing leadership, and complete administrative tasks. • Perform other assigned duties; minimal travel may be required, less than 25%.

🎯 Anforderungen

• Experience and expertise in medical writing and regulatory requirements are required by the role’s responsibilities. • Ability to produce clear, accurate scientific information and complete medical writing deliverables with minimal supervision. • Knowledge of ICH E3 guidelines and applicable regulatory standards. • Ability to follow company/client SOPs, approved templates, authorship requirements, and style and formatting guides. • Ability to coordinate quality, editorial, team, and peer reviews. • Ability to review statistical analysis plans and table/figure/listing specifications. • Ability to perform clinical literature searches and comply with copyright requirements. • Ability to provide technical support, training, and consultation. • Ability to mentor less experienced medical writers on complex projects. • Ability to work within budgeted hours and communicate project status and changes. • Minimal travel may be required, less than 25%.

🏖️ Vorteile

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