Publishing Submissions Co-ordinator (Regulatory Operations)

Job description

Role: Regulatory Operations Submission Coordinator

Location: Chancery Lane, London 1 day per week and working from home

Salary: Up to £34,000 depending on experience

Travel: 10%

Introduction:

Join Accenture and help transform leading organisations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance.

Join Accenture Operations and you will become part of the largest and most diverse group of business operations specialists in the world. You will be part of a team which provides business process excellence, implements leading cloud technology and builds and transforms client infrastructure services.

Job Description:

The Regulatory Operations Submissions Coordinator will be accountable for providing 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 an Operations Manager, the Submissions Coordinator is responsible for managing the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client. The Submissions Coordinator must also be prepared to perform presentations, both to the client as well as internally at Accenture. 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, etc).

Reporting directly to the Regulatory Operations Manager, the Regulatory Operations Submissions Coordinator's primary responsibilities will include the following:

· Submission publishing in electronic and paper formats

· 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

· Perform submission QC, resulting in a high quality final product

· Responsible for delivery of contracted commitments within budget and cost forecasting

· Drive improved capacity management of team operational resources

· 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

· 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

· Be prepared to deploy without extended notice

· Demonstrate the ability to work independently of a Regulatory Operations Manager

Desired profile

Qualifications :

What skills & experience are we looking for?




Basic Qualifications

· Industry experience
· 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 to Global Health Authorities in electronic or paper formats
· A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines
· International regulatory understanding and experience in handling business process excellence

Preferred Skills
· Ability to support a multidisciplinary project team across multiple geographic locations to build collaborative relationships
· Establish excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust
· Establish confidence in one's regulatory abilities and develops long-term trusting relationships with project team members and clients
· Promote the professional growth of self to achieve individual and organizational goals. This may include but not be limited to assisting marketing campaigns and networking with peer groups
· Proven regulatory generalist with a knowledge of drug development and knowledge of non-Europe and US markets, and may act as a subject matter expert in a specific area of regulatory operations
· Has the ability to work independently and manage stand-alone regulatory projects, as well as being an effective team worker by contributing ideas and solutions to peers ensuring all client deliverables are maintained
· Ability to manage numerous projects at once







What's in it for you?

All of our Operations professionals receive comprehensive training covering business acumen, technical and professional skills development. You'll also have opportunities to hone your functional skills and expertise in an area of specialisation. We offer a variety of formal and informal training programs at every level to help you acquire and build specialised skills faster. Learning takes place both on the job and through formal training conducted online, in the classroom, or in collaboration with others. The sheer variety of work we do, and the experience it offers, provide an unbeatable platform from which to build a career.

On top of this, we have an extensive benefits package which includes 25 days' vacation per year, gym subsidies, private medical insurance and 3 extra days leave per year for charitable work of your choice!

What are the next steps?

If this sounds like the ideal role, career and company for you, click below to apply.

About Accenture

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 specialised 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. Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, or gender identity or any other basis as protected by applicable law.

Closing Date for Applications: 31/12/2018

Accenture reserves the right to close the role prior to this date should a suitable applicant be found.