Remote Senior Medical Writer — Regulatory Submissions

Syneos Health, Inc.; États-Unis; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Syneos Health is seeking a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) for remote work based in Canada or the US. The role centers on producing high-quality regulatory submissions and amendments, coordinating cross-functional reviews, and ensuring conformance to ICH and FDA guidelines.

The candidate will mentor junior writers, manage timelines and budgets, and engage with clients and internal teams to deliver scientifically rigorous documents on time.

Qualifications

• 3–5 years of medical writing experience with protocol writing focus.
• Experience in biopharma, device, or CRO environments.
• Experience with late development programs.
• Experience in Oncology/Hematology/Cell therapy.
• Strong knowledge of FDA and ICH regulations and related guidelines.
• Experience writing regulatory documents.

Responsabilités

• Lead medical writing deliverables across studies with minimal supervision.
• Prepare clinical study protocols, amendments, CSRs, IISs, IBDs, and related submissions.
• Ensure compliance with ICH, SOPs, templates, and AMA style guidelines.
• Coordinate quality reviews and manage source documentation.
• Mentor junior writers on complex projects as needed.
• Maintain alignment with client expectations and budgets.

Connaissances

Protocol writing

Late development

Oncology/Hematology

FDA/ICH knowledge

English grammar

AMA style

Outils

Veeva/CARA

Description du poste

Syneos Health is seeking a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) for remote work based in Canada or the US. The role centers on producing high-quality regulatory submissions and amendments, coordinating cross-functional reviews, and ensuring conformance to ICH and FDA guidelines.

The candidate will mentor junior writers, manage timelines and budgets, and engage with clients and internal teams to deliver scientifically rigorous documents on time.