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Global Regulatory Publishing Associate

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  • Job
    Full-time
    Junior, Mid & Senior Level
  • Government & Politics
    Research & Development
  • Dublin

Requirements

  • Bachelor's degree in life sciences or relevant discipline.
  • Fluency in English
  • Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
  • Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g. eCTD, EU CTR).
  • Working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools
  • Familiarity with global Clinical and Regulatory HA requirements (e.g., FDA, ICH, EMA, MENA region, CH, MHRA)
  • Strong interpersonal and project management skills, and experience working in a complex, global cross functional organization.
  • Highly motivated, organized, and detailed oriented team player
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

Responsibilities

  • Accountable for electronically preparing, publishing, quality reviews, validation, dispatch & archiving activities related to clinical deliverables and global regulatory submissions.
  • Produce high quality, clinical deliverables, and global submission outputs per agreed timelines and in compliance with worldwide HA requirements, internal working practices and guidelines.
  • Act in a global capacity, and partner with various cross-functional stakeholders (e.g., Regulatory Affair Managers, Regulatory CMC Managers, Clinical Trial Leads, Nonclinical Managers, Safety and Quality associates as well as with Clinical Submission Managers, RA Operations Submission Managers and a publishing team located in multiple regions (e.g., US, EU, UK and India).
  • Support the implementation of new technology, tools, and processes, contribute to ongoing initiatives and training, and help identify continuous improvement opportunities.
  • Support submission resource planning activities, as required.

FAQs

What is the location of the Global Regulatory Publishing Associate position?

The position is based in White City, London, with a requirement to work in person three days per week.

What are the main responsibilities of the Global Regulatory Publishing Associate?

Major responsibilities include preparing, publishing, reviewing, validating, dispatching, and archiving clinical deliverables and global regulatory submissions, while ensuring compliance with worldwide health authority requirements.

What are the essential educational qualifications required for this role?

A Bachelor's degree in life sciences or a relevant discipline is required for this position.

Is experience in clinical report publishing required?

Yes, experience in clinical report and global submission dossier publishing/compilation in the pharmaceutical or related industry is essential.

What tools and systems should candidates be familiar with for this role?

Candidates should have a working knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, document management systems, and MS Office tools.

What languages must candidates be fluent in?

Fluency in English is a required condition for this role.

What is the job type for this position?

The job type for the Global Regulatory Publishing Associate position is full-time.

What kind of team environment can candidates expect?

Candidates can expect to work in a complex, global cross-functional organization with strong collaboration and support among team members.

Does Novartis have a commitment to diversity and inclusion?

Yes, Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the patients and communities served.

Is there an opportunity for career development within Novartis?

Yes, Novartis encourages associates to join their talent network to stay connected and learn about suitable career opportunities within the company.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right

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