Senior Principal Medical Writer – Regulatory Strategy Lead

Syneos Health, Inc.; Canada; Vor Ort; CAD 159.000 - 294.000; Vollzeit

Benefits dieser Stelle

Health benefits (Medical, Dental, and 

Zusammenfassung

Syneos Health, Inc. is seeking a Sr. Principal Medical Writer to lead regulatory submission documents (ISE/ISS/Clinical Overview) with a focus on quality and timely delivery.

The role requires extensive experience in regulatory writing for biopharmaceutical development and a capability to mentor junior staff. Based in Canada, you will manage cross-functional teams, ensure adherence to ICH guidelines, and contribute to global submission documents while supporting process improvements and SOP

Qualifikationen

• Bachelor's degree required; advanced degree preferred.
• 5+ years of medical writing experience in biopharmaceutical/CRO.
• Proficient in organizing and communicating clinical information with minimal oversight.
• Strong organizational and time-management skills.

Aufgaben

• Develop regulatory documents for submission to global regulatory agencies per guidelines.
• Manage medical writing projects with timelines and cross-functional coordination.
• Participate in cross-functional meetings to align deliverables and processes.
• Mentor junior medical writers and oversee multiple projects.

Kenntnisse

Regulatory writing

Project management

Cross-functional collaboration

Mentoring

MS Word

Ausbildung

Bachelor's degree

Advanced degree

Jobbeschreibung

Syneos Health, Inc. is seeking a Sr. Principal Medical Writer to lead regulatory submission documents (ISE/ISS/Clinical Overview) with a focus on quality and timely delivery.

The role requires extensive experience in regulatory writing for biopharmaceutical development and a capability to mentor junior staff. Based in Canada, you will manage cross-functional teams, ensure adherence to ICH guidelines, and contribute to global submission documents while supporting process improvements and SOP