Regulatory Publishing Manager (LATAM)

Syneos Health; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Syneos Health is seeking a Regulatory Publishing Manager (LATAM) to lead the creation, assembly, and publishing of electronic submissions to global health authorities. You will manage publication activities across programs, ensure timely delivery, and drive standards for format and quality.

The role partners with submission managers, regulatory leads, and cross-functional teams to keep submissions compliant and on schedule, contributing to efficient lifecycle management and continuous process

Qualifications

• The Regulatory Publishing Senior Manager is responsible for the creation, assembly and publishing of electronic submissions and the delivery to global health authorities.
• Leads publishing activities on a portfolio level and manages lifecycle of inter-related submissions.
• Ensures accuracy of published output to health authority requirements and company guidance.

Responsibilities

• Works independently within 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.

Skills

Regulatory publishing

Submissions management

Regulatory documentation

Stakeholder collaboration

Quality assurance

Job description

Regulatory Publishing Manager (LATAM)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

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

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

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. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.