Global Regulatory Submissions Publisher

MSD Malaysia; Ciudad de México; Hybrid; MXN 600.000 - 800.000; Vollzeit

Benefits dieser Stelle

Hybrid work arrangements

Global healthcare company

Zusammenfassung

MSD Malaysia seeks a Specialist in Global Submissions Publishing to support Regulatory Planning and Publishing. The role focuses on assembling and delivering high‑quality regulatory dossiers to health authorities, ensuring timely, compliant submissions.

You will work with authors and stakeholders to uphold regulatory standards, while mentoring others and staying current with publishing trends. Hybrid work is offered in a global healthcare setting.

Qualifikationen

• Bachelor’s Degree plus 5 years of relevant experience.
• Fluent English proficiency and experience in publishing.
• Familiarity with tools such as Veeva, Insight Publisher, Lorenz Docubridge.

Aufgaben

• Execute the publishing process for submission dossiers, including quality control and final delivery.
• Ensure timely completion and submission of dossiers by deadlines.
• Collaborate with authors and stakeholders to maintain high-quality outputs.
• Test and evaluate new publishing tools and processes; provide feedback for improvements.
• Assist in creating and maintaining administrative documentation and training materials.
• Stay informed about regulatory trends and changes affecting publishing sciences.
• Identify and mitigate risks; work with cross‑functional teams to resolve issues.
• Mentor inter-departmental and external stakeholders on regulatory requirements.

Kenntnisse

Adaptability

Compliance

Documentation

eCTD

Multitasking

Detail‑Oriented

Microsoft Word

Regulatory Affairs

Pharmacovigilance

Problem Solving

Ausbildung

Bachelor’s Degree + 5 years experience

Tools

Veeva

Insight Publisher

Lorenz Docubridge

Microsoft Office

Jobbeschreibung

MSD Malaysia seeks a Specialist in Global Submissions Publishing to support Regulatory Planning and Publishing. The role focuses on assembling and delivering high‑quality regulatory dossiers to health authorities, ensuring timely, compliant submissions.

You will work with authors and stakeholders to uphold regulatory standards, while mentoring others and staying current with publishing trends. Hybrid work is offered in a global healthcare setting.