Agile Regulatory Publishing Team

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The following post is the third of six in GlobalSubmit’s Agile for Regulatory Submissions series. GlobalSubmit’s regulatory services team employs the Agile Methodology for submission projects. By instituting Agile principles, our team has been very successful in delivering high-quality submissions ahead of schedule while maintaining constant, clear lines of communication with sponsors. To date, 75% of the regulatory submission projects executed by GlobalSubmit have been completed ahead of schedule.

The content used in our Agile for Regulatory Submissions series is adapted from the original work of Ken Schwaber and Jeff Sutherland called the Scrum Guide under the Attribution Share-Alike license of Creative Commons. Our series, which differs from the original work in the industry it describes, end product of the Agile process and professionals involved in producing the end product, is available for license under the identical terms.

What is Agile for Regulatory Submissions?

A team using the Agile for Regulatory Submissions methodology consists of a Submission Owner, Publishing Team, and a Submission Coordinator. Agile teams are self-organizing and cross-functional. Self-organizing teams choose how best to accomplish their work, rather than being directed by others outside the team. Cross-functional teams have all competencies needed to accomplish the work without depending on individuals outside of the team structure. The team model integral to Agile for Regulatory Submissions is designed to optimize flexibility, creativity, and productivity.

Agile teams deliver submissions iteratively and incrementally, maximizing opportunities for feedback. Incremental deliveries of “done” submission deliverables minimizes the risk that there is more incomplete work than expected at the end of the project.

If every submission document were 80% complete, chances are that you have a lot more work than 20% remaining. If 80% of the documents have been 100% approved, your risk of missing the submission date is much lower.

The Submission Owner

The Submission Owner is responsible for having a vision of the submission deliverables and conveying that vision to the Publishing Team and reviewers. Establishing such a starting point is the key to a successful Agile Regulatory Submission project.

The Submission Owner role requires certain skills and traits, including availability, business savvy and communication skills. The person in this role works closely with key stakeholders throughout the organization and beyond, and must be able to communicate different messages to different people about the project at any given time.

The Submission Owner is also responsible for the work of the Publishing Team. How regulatory publishing is done may vary widely across organizations, teams, and individuals.

A Submission Owner is solely accountable to the business for managing the Submission Backlog, Submission Trackers and Issue Lists. Management of the Submission Backlog, Submission Trackers and Issue Lists includes:

  • Clearly communicating which documents are being submitted
  • Creating clear deliverables that state which documents, section, or submission (if small) should be worked on and review together to create efficiencies for publishers, QC’ers and reviewers
  • Prioritizing work to best achieve a completed submission based on document production
  • Optimizing the value of the work the Publishing Team performs
  • Ensuring that the Submission Backlog, Submission Trackers and Issue Lists are visible, transparent, and clear to all, and indicates what the Agile Team will work on next
  • Ensuring the Publishing Team understands items in the Submission Backlog, Submission Trackers and Issue Lists and the work that is behind them and ahead of them

The Submission Owner may perform the duties outlined above or delegate those responsibilities to the Submission Coordinator or Publishing Team. The Submission Owner, however, ultimately remains accountable.

For the Submission Owner to succeed, the entire organization must respect his or her decisions. The Submission Owners’ decisions are visible in the content and prioritizing the deliverables to be published. Deliverables are typically one of the following – modules, sections, studies or entire submissions. No one has the authority to tell the Publishing Team to work from a different set of deliverables, and the Publishing Team isn’t allowed to act on what anyone else says.

The Publishing Team

The Publishing Team consists of professionals who incrementally deliver submissions defined as “done” at the end of each Sprint. Only members of the Publishing Team create the Submission Increment. A Submission Increment is a set of documents defined as “done” is one that is ready to be submitted to the Agency without further work. “Done” will be defined later in our Agile for Regulatory Submissions series.

Publishing Teams are structured and empowered by the organization to organize and manage their own work. The resulting synergy optimizes the Publishing Team’s overall efficiency and effectiveness.

Publishing Teams have the following characteristics:

  • They are self-organizing. No one (not even the Submission Coordinator) tells the Publishing Team how to turn a set of documents into Submission Increments
  • Publishing Teams are cross-functional, possessing all of the skills as a team necessary to create a Submission Increment
  • Agile recognizes no titles for Publishing Team members other than Publisher, regardless of the work being performed by the individual; there are no exceptions to this rule
  • Agile recognizes no sub-teams within the Publishing Team, regardless of particular domains that need to be addressed like QC; there are no exceptions to this rule
  • Individual Publishing Team members may have specialized skills and areas of focus, but accountability belongs to the Publishing Team as whole

Size of the Publishing Team

An optimal Publishing Team is small enough to remain nimble and large enough to complete significant work within a Sprint. A Publishing Team with fewer than three members results in decreased interaction and smaller productivity gains. Smaller teams may encounter skill constraints during a Sprint and fail to deliver a submission increment intended for an Agency. Having more than nine team members requires too much coordination. Large teams generate more complexity than an empirical process can manage. The Submission Owner and Submission Coordinator roles are not included in the team count unless they are performing regulatory publishing.

The Submission Coordinator

The Submission Coordinator is responsible for the team’s comprehension and enactment of the Agile for Regulatory Submissions methodology. The Submission Coordinator makes certain that the team adheres to Agile theory, practices and rules. The Submission Coordinator is thought of as a coach who helps the team realize its potential.

Coaching the team involves removing any impediments to progress, facilitating meetings, and working with the Submission Owner to make sure the Submission Backlog, Submission Tracker and Issue Log are all in working order and ready for the next Sprint.

The Submission Coordinator fills the role of servant-leader for the team, helping those outside of the team understand which of their interactions with the team are helpful and which aren’t. The Submission Coordinator helps everyone modify these interactions to create maximum value.

Traditionally, the Submission Coordinator role is filled by a former project manager or a team leader, but in theory could be filled by anyone with the desired characteristics.

How Does the Submission Coordinator Help the Submission Owner?

The Submission Coordinator helps the Submission Owner in a number of ways:

  • Finds techniques for effective submission management
  • Helps the Agile Team understand the importance of a clear and up-to-date submission tracker
  • Understands submission planning in an empirical environment
  • Verifies that the Submission Owner knows how to arrange the regulatory publishing work based on document production
  • Understands and practices agility
  • Facilitates Agile events as requested or needed

How Does the Submission Coordinator Help the Publishing Team?

The Submission Coordinator helps the Publishing Team in a number of ways:

  • Coaches the Publishing Team in self-organization and cross-functionality
  • Helps the Publishing Team create high-quality submissions
  • Removes impediments to the Publishing Team’s progress
  • Facilitates Agile events as requested or needed
  • Coaches the Publishing Team in organizational environments in which Agile is not yet fully adopted and understood

 How Does the Submission Coordinator Help the Organization?

The Submission Coordinator helps the Organization in a number of ways:

  • Leads and coaches the organization in its Agile adoption
  • Plans Agile implementations within the organization
  • Helps employees and stakeholders understand and enact Agile and an empirical publishing process
  • Serves as the catalyst for change to increase the productivity of the Agile team
  • Works with other Scrum Masters to increase the effectiveness of the application of Agile in the organization
©2015 GlobalSubmit. Offered for license under the Attribution Share-Alike license of Creative Commons, accessible at and also described in summary form at By utilizing this Agile for Regulatory Submissions content, you acknowledge and agree that you have read and agree to be bound by the terms of the Attribution Share-Alike license of Creative Commons.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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