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 approximately 373,000 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 is one of Accenture key capabilities dedicated to work on outsourcing engagements. These are long-term partnerships with clients for whom we manage and provide increasingly specialized business operations, such as finance and accounting, IT, applications development and maintenance, helpdesk services, and HR. We not only maintain key business functions for clients, we constantly seek to improve them to help our clients move ahead of the competition.
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.
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- Author and/or facilitate regulatory CMC and/or labelling documents for Health Authority submissions using Accenture or client agreed templates.
- Provide support to the Regulatory Affairs Project Manager by assisting in the deliverance of project plans and regulatory strategy.
- Collate documentation for lifecycle maintenance of marketed products, e.g., new territory extensions, variations, renewals; ensuring that all submissions adhere to regulatory requirements.
- Coordinate and maintain accurate regulatory information management of submission filing and approval in local markets.
- Compile submission packages in document management systems and initiate the required publishing activities.
- Minimum 4 years’ experience in a life sciences industry with a minimum 2 years of experience in pharmaceutical regulatory affairs in CMC or labelling.
- Understanding of different CMC or labelling document requirements for global markets.
- Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective.
- Knowledge of ICH Quality guidelines and Quality CTD content requirements.
- Ability to coordinate with cross-functional teams and manufacturing sites to obtain supportive documentation in a timely manner.
- 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.
Poznaj
Accenture Sp. z o.o.
Accenture jest globalną firmą świadczącą usługi z zakresu konsultingu, nowoczesnych technologii i outsourcingu. Ponad 281 tys. pracowników Accenture świadczy usługi swoim klientom z ponad 120 krajów świata. Łącząc niezrównane doświadczenie, doskonałą znajomość wszystkich branż i funkcji biznesowych oraz rozległą wiedzę z badań nad najlepszymi firmami na całym świecie, Accenture współpracuje ze swoimi klientami, aby pomóc im stać się wysokoefektywnym przedsiębiorstwem.
W roku finansowym zamkniętym 31 sierpnia 2013 roku, Accenture osiągnęło przychody netto sięgające 28,6 miliarda dolarów. Strona internetowa firmy to www.accenture.com.