Managing a publication-writing project
Writing a manuscript, an abstract or a poster in a pharmaceutical company or a contract research organisation is run as a project, by a team of writers, project managers, authors and approvers, through five stages: initiation, planning, execution, monitoring and control, and closure. Each stage has its own instruments, from the requirement gathering that sets the scope, through the drafting sequence, the risk register and the reasons a timeline slips, to the close-out dossier, and the project meets barriers of communication, status reporting, accountability and decision-making.
Why publication writing is run as a project, and who is on the team
Project management is essential for the expedited execution and seamless delivery of publication-writing projects with a quick turnaround time. The challenges faced in executing publication-writing projects are unique and different from those faced in conventional regulatory writing. Whatever the type of company, there is always a requirement for set processes for the seamless execution of a project, which brings the principles of project management into the picture. The development of any medical publication document can be divided into the five process groups recognised in the Project Management Body of Knowledge published by the Project Management Institute: initiation, planning, execution, monitoring and control, and closing. Among the many deliverables of publication-writing projects, the most frequently encountered are abstracts, posters and manuscripts.
A publication-writing team is made up of trained professionals with higher degrees in the life-science domain, including pharmacy, medicine and clinical research, and its structure may vary with the functionality and size of the organisation. The team comprises the principal authors, the publication writers and the project managers, and work outsourced to an agency such as a contract research organisation or a knowledge processing and outsourcing company, and the final approvers of a publication document include the product team lead, the clinical team lead, the statistics lead, the medical affairs lead, the regulatory affairs lead, legal and patents.
Initiation: requirement gathering and the scope
Project management of a publication-writing project begins with the definition of its objectives and scope. A pharmaceutical company has a publication plan ready as part of a drug's development, while a contract research organisation understands the project by communicating with the client and drafting a statement of work or a project charter, often at a kick-off meeting following a formalised handover from business development to operations. The very first step is requirement gathering, in which open-ended questions are asked to determine the project's specifications. For a manuscript, the particulars that can clarify the specifications are author documentation (debarment, legal agreements with external authors, the authorship invitation), the availability of data sources (reports, existing publications, the study protocol, the statistical plan or any other source), the need for a comprehensive literature search, which is important for reviews and meta-analyses, quality control (data and editorial checks), and the number of review cycles.
In a contract research organisation, the scope should be discussed with the client in great detail, so that the expectations of both parties are aligned. If the contract organisation is asked to use the client's standard operating procedures, they should be analysed to see whether they will affect the time management of the project. Once the scope is defined and understood, internal research and discussion devise a solution, and in internal team meetings the project manager and the medical writers discuss how to proceed. The strategies and processes for timely delivery are then defined: the project is set up in a publication planning tool, with timelines and stakeholders defined for each draft stage (initial, first, second and final draft) of the manuscript, poster or abstract. Preparatory activities to determine the deadline for each milestone include sharing a content outline and getting the client's approval of it. Cost estimates are prepared by the publication steering committee and the finance department in a pharmaceutical company, and usually during the business development phase while negotiating with the client in a contract organisation, taking into consideration the estimated project hours and the billable hours per resource.
Planning: writer allocation and project roles
The planning stage begins once all the project specifications are defined and a solution has been proposed, and its first step is assigning the project roles, which can be based on the skills documented in each writer's work profile and on the writer's position in the organisation. A writer's work profile should be well categorised by competencies, prior experience and therapeutic-area expertise. Complex manuscripts, manuscripts or posters with limited data sources, review articles and primary manuscripts can go to a senior publication writer able to interpret statistical data, while an encore abstract or poster can go to a junior one. In a contract organisation with no dedicated project managers, the publication lead might work as a writer-cum-project-manager, managing internal and external communications and deciding whether, and to what extent, assistant teams are needed, such as publication technical support, which handles the publication tracking tool and other technicalities, or the graphic design team. The availability of resources with the required skills at a given time can be tracked with online time-management tools and a common project tracker sheet, an example of which records, per deliverable, the company, the brand, the study, the writer, the subject-matter-expert and quality reviewers, the start and end dates and the actual project hours.
The availability of full-time employees should be assessed quarterly, to decide whether work needs to go to freelancers, other agencies or vendors. Overall availability is calculated from project and non-project hours, the latter covering employee leave and activities such as skillset training, self-learning, corporate activities, training in standard operating procedures and the maintenance of staff training folders. While assigning roles, the project manager should always heed the need for a back-up writer as part of the risk-mitigation strategy, who can do "fire-fighting" when the primary writer is unavailable through ill health or other emergent work. Meticulous resource planning is important to the project's successful implementation, since the definition of the project roles and the formation of the project team rest on it.
A responsibility assignment matrix is one tool for defining project roles in cross-functional or inter-departmental processes. An example matrix for writing a manuscript marks each task, from requirement gathering and project set-up to submission, as responsible, accountable, consulted, informed or omitted from the loop for the technical assistant, the project manager, the publication writer, the review team, the authors, the approvers and the graphic designer; the lead statistician is generally listed as an author, and the matrix may change with the organisation's structure and requirements. Once the roles are assigned, a work breakdown structure divides each activity into smaller tasks assigned to team members. An example for writing a manuscript runs from preparatory activities (requirement gathering and collection of data sources, author documentation and debarment checks, journal selection and literature search, and timeline set-up and resource allocation in the publication planning tool), through the draft phase (shell draft, first draft, final draft), to submission (pre-submission quality check, approvals from all stakeholders, journal submission) and post-submission activities (addressing the journal's comments and the galley proof).
Execution: the drafting sequence and the review lines
The execution phase includes working in accordance with standard operating procedures to complete the task, and for publication writing it involves drafting the document, review cycles, quality checks and addressing the comments of internal and external stakeholders. Project managers sometimes also deal with external agencies, which in a contract organisation could include translation agencies, printing and publishing support vendors, or freelance service providers. Managing offshore operations is important for contract organisations working in different geographical locations across the globe, and the operations are carried out through a global hybrid delivery model that takes geographical, cultural and chronological variation into account. The global hybrid delivery model, a relatively new approach in contract organisations to carrying out project work in accordance with the client's specifications, enables the seamless execution and delivery of a project; it involves two teams, one offshore and one onsite, which coordinate with the client and with each other to give effective output. The project manager drives execution against the plan and has to communicate regularly and openly with the sponsor.
A manuscript starts as a shell draft, carrying all the important subject-matter points as bulleted text for the introduction and discussion and as text paragraphs for the methods and results, with comments requesting input or suggestions from researchers or authors placed in it. Once the shell draft is approved, the first draft is written with input from researchers and authors; the core publication planning team reviews the scientific content of the whole manuscript and comments on inconsistencies, which the publication writers address. Once the first draft is approved, the writers prepare the second draft in accordance with the journal's guidelines. The second draft is generally considered the final draft, though additional drafts can follow from the number of review cycles and the project's requirements. The stakeholders involved in final approval are the researchers, the medico-legal team, the intellectual property team, the regulatory team, the statistics head and the clinical team head.
The line of reviews includes an in-house review by an internal subject-matter expert and by an editor. The subject-matter expert checks the scientific content, the correct interpretation of the data, the important discussion points, the tone of the overall message, whose language should not sound promotional, and the proper citation of references. The medical editors check grammar and language. In a contract organisation, the sponsor's points of contact also review the content from their own perspective. The writer-cum-project-manager acts as a bridge during these reviews, communicating and addressing comments, checking content meticulously, proposing solutions, and involving the statistician or the main author in any queries. Submission to the journal or conference involves a mock submission with the help of the publication technical expert, preparation of a submission package, and communication with the journal or conference secretariat.
Monitoring and control: the risk register and the reasons a timeline slips
The monitoring and control phase consists of risk-management measures and review by the stakeholders. Risk management is one of the most critical aspects of project management, so the risk identification and mitigation plan should always be at the project manager's disposal, and it is important to list all the possible risks the project may encounter and have an action plan ready so that the risks do not become issues. An example risk register for publication-writing projects lists, for each deliverable, the risk, its impact and the action plan.
- A conference abstract, oral presentation or poster risks difficulty in updating results from ongoing clinical trials or late-breaking trial results, whose impact is failure to disseminate the trial's key results during the conference; the publication team should plan a pre-presentation meeting with the clinical lead to incorporate the final data.
- A poster or oral presentation for a medical conference risks failing to capture important data because of limits on word count, slide count or poster size, leaving a poster with no scientific impact that does not convey the intended scientific message; prepare ancillary back-up slides for a presentation, and handouts or a QR code linked to additional information for a poster.
- A manuscript risks minimal data sources from the study sponsor, so that it may lack impact; ask for credible sources, especially the study's clinical study report, and arrange a kick-off meeting with the authors to discuss the future directions and flow of the manuscript.
- A manuscript targeting a high-tier journal with a high rejection rate might be rejected or have major revisions suggested by the journal, delaying publication; prepare a list of preferred journals with their impact factor, rejection rate and circulation from publication planning tools and discuss it with the authors, draft a pre-submission query to journals about their interest in publishing the work, and have back-up journals and their submission guidelines ready.
Corrective and preventive action is another approach to managing risks. Corrective action aims to correct an existing non-conformity and avoid its recurrence, and comes into the picture when issues have been logged or risks identified through audit findings, major client reviews and the like; preventive action aims to avoid the first occurrence of a non-conformity by implementing improvements proactively. Together they act as a solution to the issues or risks encountered, in the light of integrated quality management. Gantt charts can be used to note employee engagement and to track the project's timelines. A fishbone analysis, or Ishikawa diagram, is one more way of tracking deviation in the process and keeping corrective measures ready.
One risk-mitigation fishbone analysis for publication-writing projects sorts the reasons for timeline slippage among the publication writer, the authors, the points of contact and project management. The reasons it names include lack of communication with authors or points of contact, a writer with multiple projects going on leave, delayed responses with no scientific input, projects kept on the back burner, high-priority and no-priority publications, incomplete data sources and high expectations of writers from points of contact, a point of contact on leave, lack of support and different work styles, ad hoc requests, being unable to decide an author's timeline, projects on hold, and journal responses requiring major revisions. The measures it proposes are prompt communication, regular follow-up and a problem-solving approach; weekly updates from the writer to the respective point of contact; a back-up writer for each project and back-up points of contact; categorising projects by timeline and difficulty for better allocation; monthly meetings of points of contact and writers to discuss project details and the support needed; assessing writers' workload before accommodating any ad hoc request; the writer following the same process with all points of contact for timelines and documentation; always sending timelines to authors and points of contact before starting a project; the writer starting communication about the project in advance; and the writer checking the status of submitted manuscripts regularly.
Closure: the close-out dossier and the lessons learnt
Project closure involves close-out documentation and review meetings. The close-out documentation is a final information dossier of all the relevant project logs, minutes of meetings, business emails and the like, holding the project's specifications, the decisions made, the measures employed and the overall course of the project. The close-out dossier captures risks and issues, project quality, lessons learnt, and an overall analysis of the achievements made and the pitfalls encountered during execution. Lessons learnt in each phase, from the kick-off meeting to delivery, can be discussed and shared as a group, and the mistakes made and the solutions found go into a knowledge base for future reference; special lessons-learnt meetings are arranged to broaden the knowledge and troubleshooting experience of the people involved. A data sheet of detailed information about the project's compound, such as the molecule identifier, history, generic term, drug class, and the pharmacology, safety and efficacy studies of the molecule, creates a knowledge base for future use. Closure also keeps all documents in an inventory, such as issue logs and logs of project risks and mitigation strategies, and archives the published deliverable.
Barriers to project management, and process improvement
Barriers to effective project management include communication hurdles, a lack of status-reporting measures, a low accountability culture, and conflicts in decision-making. Communication hurdles include language barriers and different interpretations of the intended message, and working with non-English speakers can pose significant problems through incomprehension or misunderstanding of requirements, which the services of translation agencies and interpreters can help overcome. The project manager should communicate clearly with the points of contact, negotiate effectively with vendors, have good interpersonal skills, and be able to manage resources and resolve conflicts. Each person working on the project should be given ample freedom as well as accountability for the project's seamless execution, and there should be an efficient risk-reporting system so that risks do not become issues. The behavioural and communication aspects of a manager are instrumental to the progress of the project.
A project's success lies in process-improvement methods and the diligent contribution of the assigned resources, and process improvement can further help expedite delivery timelines and reduce costs. Capability maturity model integration is a process-improvement plan that pharmaceutical companies and contract organisations can implement in medical affairs or medical writing departments, and for a contract organisation its appraisal additionally wins the client's confidence and can help attract new projects and business. Lean six sigma is a business-improvement strategy that aims to improve team performance by integrated efforts and by removing redundancy; it improves cross-functional teamwork in any process-driven service industry and reduces the cost of poor quality that results from late delivery, customer complaints and misdirected problem solving. There have been attempts to harmonise and implement lean six sigma and the principles of the Project Management Body of Knowledge in pharmaceutical organisations. Novel and innovative approaches that minimise process hurdles and make project execution smooth and error free are the future ideals of project management.