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Regulatory Operations Senior Analyst

Job Location: Warsaw

Regional Description: Poland

Job Number: 00589953

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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 435,000 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 Operations helps clients achieve new value and productivity from their business processes by applying analytics, process acumen and industry expertise to the transactional data and processes we manage and operate on our clients’ behalf.


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



Your future is waiting – just make a step forward!

Would you love to work with passionate people from all over the world?

Are you dreaming about using your foreign language skills and at the same time gaining knowledge?

Take a just one look and decide if Accenture is a place for You!



Accenture’s Accelerated R&D Services (ARDS) bring a fully integrated, robust business service that delivers enhanced processes across the Clinical, Regulatory and Pharmacovigilance functions around the globe.

Key responsibilities may include
  • Coordinate submission documentation (new and lifecycle submissions). Leverage publishing team as appropriate. 
  • Submissions technical review and validation.
  • Coordinate final submission review and approval by appropriate stakeholders. 
  • Finalize and dispatch submission to client affiliates or Health Authorities as required.
  • Create and maintain initial and life cycle events in regulatory information management (RIM) system. 


  • Experience in publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (NDA, MAA, NDS, MAA, 510k) to Health Authorities in eCTD, NeeS, eSub or paper formats. 
  • Knowledge of regulatory submission requirements and understanding of the nuances of different submission components. 
  • Experience with publishing software and tools used throughout the pharmaceutical industry and in regulatory information management (RIM) systems. 
  • Minimum 2 years of experience in an area of expertise (e.g., regulatory documentation publishing, RIM data management).
  • Knowledge in handling registrations and maintenance of pharmaceutical products from a regional or local perspective.


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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