[Hiring] Regulatory Publishing Manager @Syneos Health

Role Description

The Regulatory Publishing Senior Manager is responsible for the creation, assembly, and publishing of electronic submissions and the delivery to global health authorities in an efficient and timely manner. The role is accountable for leading publishing activities on a portfolio level and responsible for the maintenance and lifecycle management submissions that are inter-related and dependent on multiple concurrent submissions. Can lead complex submission work across programs. This role will work with stakeholders and project teams for the timely delivery of content to be published, as well as drive for project teams the standards and expectations of format. This role is responsible for the accuracy of published output to Vertex and industry standards and health authority requirements. The Regulatory Publishing Senior Manager will be responsible for leading process improvements for the accurate and quality driven execution of submissions.

Key Duties and Responsibilities

• Works independently within the publishing/content 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 achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.

Qualifications

• Equivalent experience, skills, and/or education will also be considered.

Requirements

• Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
• The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.