Job description

Job Purpose

Perform assessment, quality control and publishing of NIBR scientific documents to ensure content, format and technical quality are consistent and compliant with internal and external guidelines and requirements. Provide first-line user support for electronic Document Management System and support project leads with system maintenance and roll-out activities.

Major Accountabilities

1. Perform source data verification (SDV) and technical (Novstyle) quality control (QC) of NIBR submission documents (simple to medium complexity) to ensure adherence to content and format quality standards. Collaborate with globally located NIBR scientific and operational personnel, to ensure finalization of the documents, according to timelines and quality requirements.
2. Provide advice when required to authors on SDV requirements, technical formatting processes and the use of clients document management systems.
3. Compile, integrate and publish applicable Client documents with word processing, electronic publishing, and document management systems in collaboration with the responsible author(s).
4. Work with external consultants (vendors) to coordinate outsourced activities related to the processed tasks.
5. Serve as a Business Administer for the Non-Clinical documentation repository, thus providing support for new user account creation and troubleshooting of routine system workflow issues.
6. May contribute to the generation of ideas on areas for optimization and innovation and assist in process improvement activities related to document quality management and submission management in client
7. Support with Merger and Acquisition actives, as it relates to the integration of acquired assets/documents into Novartis’ electronic Document Management Systems.
8. May provide input to DQM onboarding and training materials.

Key Performance Indicators

• Completion of an adequate number of regulatory documents (taking into account complexity and size) in accordance with the timelines specified by department KPIs
• Timeliness of deliverables, such that both individual document review KPIs are satisfied, and overall project timelines are adhered to.
• Proactive and collaborative communication with key stakeholders based on feedback from internal colleagues and customers.
• Adherence to Novartis Values and Behaviors and code of conduct.

Job Dimensions

Number of associates:
None
Financial responsibility:
(Budget, Cost, Sales, etc.)
None
Impact on the organisation: Timely finalization of high-quality regulatory documents reflective of source documents and format requirements, to ensure quality requirements of NIBR contributions to submissions are met.

Ideal Background

Education (minimum/desirable): Undergraduate degree preferably in a scientific discipline or business vocation or equivalent work experience
Languages: Business-level English (oral and written)

Experience/Professional Requirement:

• Relevant work experience with electronic document management systems (e.g., Documentum, Veeva Vault etc.) and document review.
• Basic understanding of non-clinical, clinical and regulatory deliverables relevant to submission dossiers.
• Demonstrated ability to work successfully within a matrix environment and influence cross functional teams.
• Flexible and detail-oriented approach to documentation management, as appropriate.
• Experience with and ability to understand compliance practices which include GxPs and Standard Operating Procedures.
• Strong oral and written communication skills and customer service mindset.
• Proficient in the use of Microsoft office suite (e.g. MS Word, Excel, PowerPoint).
• Self-starter with a proven ability to prioritize work, multi task, display customer centricity and manage time appropriately, in a fast paced/high volume environment.

Job Type: Contract

Pay: $45.00 - $55.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• East Hanover, NJ 07936: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: One location

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