Senior Principal Regulatory Oncology Medical Writer

Syneos Health, Inc.; Montrouge; Sur place; EUR 97 000 - 180 000; Plein temps

Résumé du poste

A leading healthcare solutions company seeks a Senior Principal Medical Writer to develop regulatory documents for global submission. The ideal candidate has extensive experience in clinical writing, project management, and mentoring junior staff. Responsibilities include overseeing medical writing projects, collaborating with cross-functional teams, and ensuring adherence to regulatory standards. Compensation ranges from $114,000 to $210,900, with benefits such as health coverage and flexible time off.

Prestations

Company car or car allowance

Health benefits (medical, dental, vision)

Company match 401(k)

Employee stock purchase plan

Flexible paid time off

Qualifications

• Broad understanding of clinical research processes and regulatory document standards.
• Experience in developing clinical documents for regulatory submissions.
• Ability to mentor less experienced writers.

Responsabilités

• Develop regulatory documents for submission to global agencies.
• Manage medical writing projects and timelines.
• Participate in cross-functional meetings for medical writing deliverables.
• Review documents associated with projects.
• Define and write standard operating procedures for document preparation.
• Mentor junior medical writing staff.

Connaissances

Regulatory document development

Project management

Mentoring

Cross-functional communication

Process improvement

Scientific writing

Description du poste

A leading healthcare solutions company seeks a Senior Principal Medical Writer to develop regulatory documents for global submission. The ideal candidate has extensive experience in clinical writing, project management, and mentoring junior staff. Responsibilities include overseeing medical writing projects, collaborating with cross-functional teams, and ensuring adherence to regulatory standards. Compensation ranges from $114,000 to $210,900, with benefits such as health coverage and flexible time off.