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 482,000 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 provides business process services for specific functions, including finance and accounting; procurement and supply chain; and marketing & sales. We operate business processes with a combination of talent and data, artificial intelligence, analytics and digital technologies, helping clients to improve their productivity, customer experience and performance.
This role requires the holder to demonstrate a high level of regulatory operations expertise in one or more global regions (e.g., US, Europe, Japan, Canada, Australia, Emerging Markets). The Regulatory Operations Sr Project Coordinator is expected to provide technical guidance across all aspects of regulatory operations in order to ensure generation of the highest quality regulatory submissions for the client. Under the direction of a Operations Manager, the Sr Project Coordinator is responsible for managing the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client. The Sr Project Coordinator must also be prepared to perform presentations, both to the client as well as internally at Accenture.
- Control submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high quality final product
- Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner
- Work with the Operations Manager to develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals
- Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the duration of the project
- High level of communication with project team
- Regular communication with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction
- Ensure that specific Project Specifications, if they exist, are strictly adhered to throughout the duration of the project
- Take instruction and perform tasks as necessary as directed by reporting manager
- Bachelor’s degree or the equivalent in work experience
- Minimum 3 years of industry experience.
- Minimum 1 year experience in Project Management.
- Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective.
- Experience with publishing software and tools used throughout the Pharmaceutical industry.
- Experience in coordination and publishing of regulatory submissions for Investigational (IND, CTA) or Marketing Applications (NDA, MAA, NDS, MAA, 510k) to Global Health Authorities in eCTD, NeeS, or paper formats
- A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
- Excellent international regulatory understanding and experience in handling business process excellence.
What we can offer
- Using foreign language and new technology solutions daily, cooperating with various global Clients.
- Constant support and clear development path from your first day at office – dedicated Buddy, who will help you in adjusting to the new workplace.
- Focus on your strengths and continuous feedback enable fast professional growth, as well as new skills building by various online and classroom trainings.
- Inclusion and diversity in practice: truly multicultural environment; we support LGBT, people with disabilities and parents. In our culture of equality, people are truly valued for their differences and free to be who they are.
- A flexible approach that allows an appropriate work-life balance where sports activities, outings, volunteering initiatives are part of our regular day-to day life.
- Commitment to reducing our environmental impact in terms of carbon, water and waste across Accenture facilities and in the communities in which we work and live by joining different initiatives.
- Full work comfort – private medical care, life insurance, access to MyBenefit platform, bonuses for referring new employees.
- Modern, ecological office in city center with convenient connection for all means of transport (incl. chill room, game room, free bicycle parking and coffee-breaks at terrace).
Equal Employment Opportunity Statement
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
Accenture is committed to providing veteran employment opportunities to our service men and women.
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With over 450,000 employees in more than 120 countries, Accenture solves our clients' toughest challenges by providing a broad range of services and solutions in strategy, consulting, digital, technology and operations.