Submission Readiness Document Manager

Role Overview

The Submission Readiness Document Manager plays a vital role in ensuring clinical documents are accurately prepared and compliant for regulatory submissions. Based in Dublin, Ireland, this position demands close collaboration with global teams to optimize clinical document management practices, supporting timely and precise regulatory processes.

Key Responsibilities

• Oversee the submission readiness of clinical documents, verifying adherence to regulatory standards and quality criteria.
• Manage the technical editing and formatting required for regulatory submission documents.
• Guarantee documents comply with Health Authority guidelines, Good Clinical Practice, and company protocols.
• Support the rollout of submission readiness strategies and enforce the use of standardized templates.
• Work closely with cross-functional teams to ensure delivery of high-quality documents within deadlines.
• Monitor vendor activities, evaluate service metrics, and promote continual improvement initiatives.
• Serve as the escalation point for submission readiness concerns and resolve related operational problems.
• Identify process risks, trends, and deficiencies, and apply suitable corrective measures.
• Act as a Subject Matter Expert on submission readiness processes, associated tools, and training materials.
• Assist in audits and inspections by performing root cause analyses and implementing corrective and preventive actions.

Qualifications and Experience

• Bachelor’s degree in life sciences, healthcare, pharmacy, or information management is required.
• Three to five years of experience in clinical development, clinical operations, or a related field.
• Expertise in clinical document management processes and comprehensive knowledge of regulatory requirements.
• Advanced understanding of best documentation practices including data integrity and good documentation principles.
• Experience with document management systems and familiarity with their structures and functionalities.
• Capability to handle projects in a global and cross-functional environment.
• Strong organizational, communication, and tracking skills.
• Ability to work independently and manage demanding priorities effectively.

Compensation and Benefits

• The expected annual base salary ranges between 55,370 and 102,830 Euros, depending on skills, competencies, and experience.
• Potential eligibility for a performance-based bonus.
• Access to a range of competitive benefits including insurance and retirement plans, wellbeing resources, global recognition programs, and at least 14 weeks of paid parental leave.
• Flexible and hybrid working options are available where applicable.

Additional Information

This role is based in Dublin without relocation support; applicants should be able to commute independently. Novartis emphasizes pay equity and is dedicated to maintaining an inclusive work environment reflective of diverse communities. The company abides by gender-neutral policies for salary determination and promotes a supportive culture for employees. Benefits and compensation vary by location based on legal requirements and collective bargaining agreements. Comprehensive details about compensation and collective bargaining will be provided during the recruitment process.

Novartis invites candidates passionate about contributing to patient health and innovation to join a collaborative and inspiring community that strives for breakthroughs in medicine.