Regulatory Operations Submission Coordinator

Job description

Role: Regulatory Operations Submission Coordinator

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

Salary: Up to £37000 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.

We are constantly seeking new ways to achieve high performance in our clients' business operations! We provide technology-enabled business process services to deliver business outcomes and are constantly seeking new ways to achieve high performance in our clients' business operations.

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.

What responsibilities will you have?

· 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
· Be prepared to deploy without extended notice

Assembly of eCTD

· Demonstrate expert knowledge of eCTD including eCTD viewing and validation software.
· Demonstrate in depth understanding of submission compilation and application requirements (preferably more than one region).
· Extensive knowledge of applicable regulations (preferably in more than one region).
· Generates regulatory dossiers and follows through during the review processes (CTA, Marketing applications) supplements and variations)
· Compile lifecycle maintenance submissions, such as annual reports, variations, and supplements)
· Demonstrate expertise in performing eCTD submission publishing (for example, leaf structure and backbone).

Assembly of Other Submission Formats

· Demonstrate understanding of submission compilation and application requirements.
· Basic understanding of applicable regulations.
· Demonstrate expertise in submission publishing for other submission formats (such as NeeS or paper).
· Demonstrate proficiency in the use of publishing tools to generate required formats

Quality Control

· Demonstrate expertise in performing final document and submission reviews and quality control checks

Technical skills

· Interpret and apply ICH and health authority-specific guidance to projects.
· Answer regulatory submission questions from the client.

Technical Skills

· Use regulatory knowledge to propose new initiatives.
· Generate detailed Project Plans for complex submissions, therapeutic areas, and/or client portfolio.
· Provide training internally.

Customer Service and Communication

· Request information from the stakeholders or sponsors.
· Interact with the client on submission projects.
· Answer questions from the client regarding submission projects.
· Be able to travel onsite and represent Accenture at the client location for submission projects.

Customer Service and Communication

· Perform kickoff meetings for submission projects.

Problem Solving Techniques

· Solve problem with regards to issue resolutions and possible rework scenarios.
· Handle timeline pressures and display positive attitudes to client and team where applicable.
· Be the source for innovation and gained efficiencies.

Interpersonal Interaction

· Work in team environment.
· Interact with all members of Regulatory Affairs and Operations group on a regular basis.
· Work well under pressure.

Attention to Detail

· Demonstrate attention to detail

Mentoring

· Mentor the Regulatory Operations Publishing Associate and Regulatory Operations Project Coordinator.

Project Management

· Track submission timelines, deliverables, and metrics.
· Maintain regulatory databases.
· Demonstrate the ability to work on numerous projects (multi-task).

Desired profile

Qualifications :

What skills & experience are we looking for?

·  Ability to support a multidisciplinary project team across multiple geographic locations to build collaborative relationships with client, health authorities and other experts in the regulatory field
·  Establishes excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust.
·  Establishes confidence in one's regulatory abilities and develops long-term trusting relationships with project team members and clients.
·  Should 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-EU/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.
·  Attention to detail (ATD).
·  Ability to work on numerous projects (multi-task).
·  Ability to work under pressure.

What academic qualifications do you need?

·  Bachelor's degree or the equivalent in work experience
·  industry experience.
·  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'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: 30/11/2017

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