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Regulatory Operations Publishing Associate/ Specjalista ds. regulatory operations

Job Location: Warszawa

Regional Description: Polska

Job Number: 00517222

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- Job description

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions—underpinned by the world’s largest delivery network—Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With more than 375,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.


Accenture’s Accelerated R&D Services bring a fully integrated, robust business service that delivers enhanced processes across the Clinical, Regulatory and Pharmacovigilance (PV) functions around the globe. Our solutions, supported by outsourced operational activities and facilitated by customizable technology and infrastructure, allow pharmaceutical companies to bring drugs to market faster, at a reduced cost and with reduced  execution risks.

This position is responsible for basic electronic submission tasks which underpin the Unit’s electronic submission output service, including bookmarking and hyperlinking of regulatory documentation for submission to multiple regulatory agencies.


Repetition of tasks is a part of this role, yet demands flexibility in taking on responsibilities connected to the role and an attention to detail to ensure high quality deliverables. 


This position has daily contact and interaction with peers in a team environment as well as with team leaders.



Key responsibilities:

  • Project Document Processing including:
    • Bookmarking
    • Hyperlinking
    • Identifying Issues
    • Initial RO Reviews
  • Completion of assigned tasks with a high degree of quality in a timely manner
  • Use of MS Office and Adobe Acrobat programs as well as Internal and External Publishing Tools
  • Reading and learning external guidance documentation related to electronic submissions such as Health Authority Guidance documents or ICH guidance.
  • Document level Quality Control
  • Assistance with Accenture’s internal development projects
  • Submission-level publishing activities
  • Master’s degree in natural science, life sciences or pharmacy.
  • Knowledge of eCTD including eCTD software.
  • Proficiency in submission publishing for other submission formats (such as NeeS or paper).
  • Proficiency in the use of publishing tools to generate required formats.
  • Proficiency in the use of Adobe Acrobat tools to generate submission ready content.
  • Excellent written and verbal communication skills in English.
  • Establishes excellent working relationships with peers and team members through integrity, credibility, reliability and trust.
  • Attention to detail.
  • Ability to work on numerous projects and under pressure. 


We offer


  • The ability to use your knowledge of foreign language on a daily basis at work (we serve our Clients in almost 30 foreign languages)
  • Experience with a range of Clients and technology solutions which provides professional relevance
  • Operating according to Lean Six Sigma philosophy
  • Collaborating and learning from diverse and talented colleagues helps you “raise your game”
  • Trainings and development tailored to help you achieve your potential
  • New Joiners Programme including trainings
  • Opportunity  to engage in Corporate Social Responsibility initiatives
  • We also think about your social life, at Accenture you will be able to take part in different initiatives like Book Club, International Cuisine Club, Accenture Runners Club, family events, cultural meetings, photography classes, climbing, soccer, swimming and many others.
  • Social benefit packages including: private medical care, Sodexo vouchers, Benefit sport club cards, life insurance
  • Friendly work atmosphere in multicultural environment


When applying please enclose the below statement:

"I hereby express my consent to process my personal data included in my job offer by Accenture Sp. z o.o. or any other entity of the Accenture group for recruitment purposes and once the recruitment process is closed, I agree that Accenture Sp. z o.o. with its registered seat in Warsaw, 00-121, ul. Sienna 39 or any other entity of Accenture group places and processes my personal data in its database. I also express my consent to sending my personal data to third parties within the Accenture group pursuant to the Personal Data Protection Act of 29th August 1997 (Journal of Laws of 2002, No. 101, position 926 as amended). I submit the data voluntarily. I have been informed about the right of access to the content of my data and about the possibility of correcting them."

Check out all our job vacancies at our website:
www.accenture.pl/operationswarsaw

Accenture does not discriminate employment candidates on the basis of race, religion, color, sex, age, disability, national origin, political beliefs, trade union membership, ethnicity, denomination, sexual orientation or any other basis impermissible under Polish law.”

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