Senior Regulatory Publishing Lead (Remote)

Syneos Health, Inc.; Bogotá; Híbrido; COP 280.260.000 - 373.680.000; Jornada completa

Descripción de la vacante

The Regulatory Publishing Senior Manager at Syneos Health is responsible for the creation, assembly, and publishing of electronic submissions and their delivery to global health authorities. This role leads publishing activities across a portfolio, ensuring accuracy and adherence to health authority requirements.

You will collaborate with submission managers and regulatory leads to meet timelines, manage interdependencies, and drive process improvements.

Formación

• Experience in regulatory publishing and electronic submissions is required.
• Ability to collaborate with cross-functional teams and manage submission timelines.
• Knowledge of health authority guidelines and template specifications.

Responsabilidades

• Works independently within publishing systems to create published output for submission.
• Creates and assembles all components of defined submissions in required format as per health authority guidance.
• Validates submissions through the application of acquired experience.
• Manage portfolio views of upcoming submissions and publishing interdependencies.
• Collaborates with submission managers and regulatory leads for submission preparation and timelines.
• Liaises with functional source areas to ensure documents are compliant and submission ready.
• Collaborates with regulatory document authors to ensure documents comply with regulatory and company guidance/template specifications.

Descripción del empleo

The Regulatory Publishing Senior Manager at Syneos Health is responsible for the creation, assembly, and publishing of electronic submissions and their delivery to global health authorities. This role leads publishing activities across a portfolio, ensuring accuracy and adherence to health authority requirements.

You will collaborate with submission managers and regulatory leads to meet timelines, manage interdependencies, and drive process improvements.