Remote Senior Medical Writer for Regulatory Submissions

Syneos Health, Inc.; Oregon; Ibrido; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Syneos Health, a leading life sciences services organization, seeks a Sponsor Dedicated Senior Medical Writer for Regulatory Submission Documents, remotely based in the US or Canada. Role focuses on high-quality medical writing for protocols, amendments, and submissions.

You will lead creation of clinical study documents, ensure adherence to ICH/FDA guidelines, and mentor junior writers while collaborating across clinical, data management, biostatistics, and regulatory affairs to deliver on time

Competenze

• 3–5 years of experience in medical writing.
• Experience with protocol writing.
• Experience in biopharmaceutical, device, or contract research organization industry.
• Strong understanding of FDA and ICH regulations and good publication practices.

Mansioni

• Lead the completion of medical writing deliverables with clear, accurate data.
• Coordinate activities across departments with minimal supervision.
• Lead the resolution of client comments and ensure regulatory standards are met.
• Mentor and guide less experienced medical writers on complex projects.
• Develop deep expertise on regulatory guidelines affecting medical writing.
• Manage project budgets and timelines, communicating status to leadership.
• Conduct literature searches and ensure copyright compliance.

Conoscenze

Medical writing

Protocol writing

Regulatory knowledge

Strumenti

Veeva/CARA

Descrizione del lavoro

Syneos Health, a leading life sciences services organization, seeks a Sponsor Dedicated Senior Medical Writer for Regulatory Submission Documents, remotely based in the US or Canada. Role focuses on high-quality medical writing for protocols, amendments, and submissions.

You will lead creation of clinical study documents, ensure adherence to ICH/FDA guidelines, and mentor junior writers while collaborating across clinical, data management, biostatistics, and regulatory affairs to deliver on time