Managing a client project
A writing project delivered to a client under contract runs well when expectations are agreed before the work starts, someone owns each stage, the hours, the timeline and the scope are watched while it runs, and both sides communicate so that the other can act. A rush job, a client meeting away from home, a place inside a client's team from outside it, and the common emergencies each ask something more of the writer.
What a client project needs to run well
An experienced contract-research writer holds that a writing project delivered under contract needs three things to run well: clear ownership, so that someone is accountable and responsible for everything that happens; realistic requests and timelines, because however hard anyone tries an unrealistic plan cannot be managed effectively; and effective communication between both sides of the contract, those doing the work and those who requested it. Without them the project is delivered late, or without profit or with reduced profit, and almost certainly leaves the writer very stressed.
Setting up the project
Expectations on both sides need to be very clearly understood, so the first step is a full review of the contract as soon as the writer is assigned, while there is still time to address problems. The review establishes what the writer is supposed to provide, what the client thinks the writer is providing, and the scope of the project. Where the contract is unclear or silent, the writer should state their understanding to the client and ask the client to confirm it. A difference in expectation between client and writer is one of the most common problems with projects, and one that does not become apparent until halfway through leaves the project in real trouble.
Besides knowing what the project is about, the writer needs to know who is responsible for what. The writer should do their own job rather than other team members' jobs as well, and where others are not doing what they should, make them aware of it.
Kickoff meetings are universally important for medical communication projects, and they give the writer a chance to make a good first impression for themselves and the company they represent. A successful kickoff can "foster rapport, trust, and open/transparent communication between team members", align participants' goals and expectations and clarify who is responsible for which task, and at it participants can identify milestones and timetables and define the deliverables.
A typical kickoff meeting runs through a set of stages. Introductions: learn each participant's name, contact information and team responsibility, and take notes on the team's dynamics and hierarchy and on each person's commitment, flexibility and helpfulness, which help in planning deadlines and making assignments. Project background: learn it, to understand the project's context and how it might relate to other projects. Goals: ask "What does successful completion of the document actually look like?"; making sure everyone agrees on the goals gives each team member a clearer vision of the end product. Scope: determine the scope of the project and of each team member's responsibilities, which in many cases timelines drive. Scope creep can occur when a well-meaning person takes on more tasks than were originally agreed, potentially derailing the schedule; to combat it, refer often to the statement of work, adhere to it and remind clients of the tasks negotiated in it, to prevent delayed deadlines and strained budgets. Client processes, workflow, milestones and timelines: "You want timelines and milestones to make sure the process is progressing"; discuss potential delays and "build a cushion into the timeline" to accommodate delays, long review cycles and conflicting deadlines. Deliverables: find out what will be provided to the writer, including drafts and drop-in content, and when, and define what will be provided to the client, including drop-in content and multiple sections, and when. To close, make sure everyone understands the consensus decisions, action items, tentative timelines and deliverables, and follow up on them with the primary contact in a detailed email.
Time spent at the beginning of a project is time well spent. It is easy to rush into writing on receiving a new project, but the most effective way of working is to set things up first: the folder system for filing in place and, where appropriate, a project-specific guideline so that all the writers on the project work to the same rules. The guideline brings consistency, saves repeating things over and over, and gives a better-quality document at review and quality control because everyone has worked to the same instructions.
The writer should not provide more than the client requires. Many medical writers are perfectionists, which is good in some ways but not appropriate when providing a service to a client: presenting everything the same way may seem worthwhile, but if the client does not want or need it, the time should not be spent creating that perfect document. Any issue that needs clarification should be followed up as soon as possible with the project manager or the client, rather than put into the draft as a query that takes two weeks to come back.
A writer should keep educating themselves and try to understand the motivations of the stakeholders they work with, such as clinical, regulatory, sales and marketing staff. These stakeholders all look at the world differently and want to see different things in the writing, and a writer will never know how to make them happy without understanding them.
The stages of an agency project and who owns each
Projects in a medical communications agency are scheduled in a similar way however complex they are, and each stage has its responsible parties. The pharmaceutical client's medico-marketing department sets the project goals. The agency sets out the proposal. Client and agency agree the project, the budget and the deadlines. The agency recruits external medical experts as needed, as writers, consultants or members of a scientific committee, alongside designers and technical partners. The agency writes the content and generates the project's visual identity. The client's medico-marketing and regulatory departments review the contents and the visual identity. The agency prepares the format and layout of the communication product with its internal or external partners, such as a design studio, a video team, an event agency, a logistics team, professional translators, IT developers and publishing houses. The client's regulatory department and the external medical experts validate and approve the content. The agency delivers the communication product to the client's medico-marketing department.
The external medical experts are extremely busy physicians whose contributions matter from the beginning of the project to its last stage. Four tips help in liaising with them professionally. Remind them of tasks and deadlines constantly by email or telephone, get their mobile numbers, and do not remind them only when the deadline is drawing near. Leave messages that are short but carry complete and exact information. Be persistent but not forceful. Be personal, with a face-to-face meeting once in a while.
Hours and timeline while the work runs
The writer should know how many hours the project needs and, as it proceeds, check whether the hours used are about right given the work still to come. If there is a problem, the writer should go back to the client proactively and explain that the work will take more hours than expected, and why.
For a service provider, maintaining 100% time compliance is a very important criterion, and one medical writer at such a provider found the work pressure evident because of it. She planned each day's expected deliverables while staying open and flexible, especially where a regulatory document needed contributions from several authors and reviewers, and was learning to track metrics in real time. Filling in a timesheet at the end of each day gives a reality check of how much time a document takes and how much more goes to communication with the team, internal and external, to literature searching and to planning.
The writer should establish who is responsible for the timelines and who must be told of changes to them, and make sure to be part of that loop. On some projects the client or the project manager has altered the timelines without anyone telling the medical writer who was actually doing the writing.
Work can also stall outside the writer's hands. One medical writer named as the most challenging part of the job a project whose production and printing stalled with the client or with the legal and regulatory department for so long that by the time the final draft was approved, it needed updating.
Changes of scope
Changes to the scope of a project are normal as it goes along, and one writer with more than twenty years in a contract research organisation had yet to work on a project where none were asked for. The writer should be flexible to the changes the client requests and equally clear about what can and cannot be achieved. The writer should not over-promise, nor, worse, let the project manager or an equivalent colleague over-promise. If something clearly cannot be done in three days, the writer should say so up front; that may cause a problem at the beginning, but after the difficult discussion the work proceeds to a realistic plan.
Understanding the reasons behind a request helps the writer reach the right solution. A request to finish sooner may come from pressure from higher management, or from another part of the submission that needs the writer's document before it can be completed, and the more the writer understands such reasons, the more likely a good compromise becomes.
A writer should not feel pressured into giving immediate answers, as when a teleconference asks for agreement to a draft by Wednesday or to additional tables. It is perfectly acceptable to say that the request needs looking into and discussing with colleagues, and coming back later that day or within a short time gives a more accurate answer. Sometimes the answer has to be no, which a writer has to learn to say, and to say nicely. A refusal should try to give the reason and suggest an alternative, and a writer who feels unable to say no can say they will discuss it with their manager or colleagues first, or, where their saying no is causing a problem, have someone higher in the organisation say it. Saying no is not failing; it is part of effective project management.
Quality, time and cost are related: when a client asks for a shorter timeline, either cost rises, perhaps by bringing in more people, which is sometimes but not always possible, or quality suffers, because a project that could have been done in less time would have been arranged that way before. That relationship belongs in view when looking for a solution to any problem that comes up.
A request can be unrealistic because it falls outside the writer's area of expertise, and then the writer can consider whether another department or organisation could provide that service, and offer the client other answers rather than doing work that is outside their area and will cause problems. An unrealistic timeline calls for alternative solutions from a little outside the box, such as delivering the document in two sections, or delivering it when the reviewer returns from holiday rather than leaving it on their desk for a week while they are away. There are usually ways to find an alternative to a timeline that appears unrealistic at the beginning. The client should understand that an unrealistic timeline will affect quality, and the writer should try to propose alternatives that give more time for the work and are still acceptable to the client.
Three examples of problems that call for such creative solutions are a client who needs the final clinical study report early because their publishing system will take five days before the regulatory submission; a client who asks to see a version of the report before the first draft, just to see how things are going; and a final manuscript draft that suddenly has to go to colleagues in the United States for review after draft one, draft two and the final draft are done. The last might have been dealt with before it became a problem, and the answer to all three is to communicate properly with the client or the rest of the team.
Communication the other side can act on
Direct communication is always best, because it is less likely to be misunderstood. The writer tells the other side what they are doing and asks what the other side is doing, as in "we will update the document", not "the document needs to be updated by us", and gives clear and precise answers.
A them-and-us approach, towards the client or towards the rest of the team, should be avoided. On a project that is not going well it is easy to get frustrated with team members who seem not to be doing their job, and although that may be true, accusing people does not help the communication and leaves them demoralised. While the problem is live, the question is where to go from here rather than what caused it, which belongs to the lessons learned afterwards.
The writer should listen to what is being said and try to understand the other side, and where it is not clear, ask the other person to explain it again in a different way. Unless both sides understand each other, the project does not really stand a chance of running smoothly.
Information should be shared, saying not only what the writer will do but why: if a delivery has to be delayed, the writer explains at least the outline of why. People should not be drowned in unnecessary information, though, because they cannot take it all in and miss the important part, as with a page-long email whose reader is probably no longer concentrating after the first paragraph.
Potential problems should be identified proactively, and when a project is drifting, the client should be told as early as possible and offered possible solutions. Telling the client there is an issue together with a possible solution is a win-win, and leaves the client thinking the job is being done well.
Further suggestions for managing an agency's client relationship aim to prevent stressful situations over deadlines. The client is kept informed of the project's status through regular reporting and follow-up; instructions and directives are formalised by email and telephone; the client is guided in decision-making with recommendations suited to their needs; and the client is warned ahead of the project's launch about inevitable time lags and timeline constraints.
Channels and meetings
The form of communication should match the problem. Email correspondence that goes round in circles needs to be stopped and moved to a telephone call or a face-to-face meeting; it becomes very clear when emails are not solving the problem, and email number 23 in an argument will not help. Quality issues and serious timeline issues need a telephone call or personal contact rather than email, because important issues do not get resolved by email and avoiding a personal discussion of a real problem does not look professional. Information that needs no discussion needs no meeting. Where a memo, an email or a brief report covers the same information better, it should be sent instead of holding a meeting.
A freelance slide-deck project that fell apart over mixed messages by email came down to communication problems, and its lesson is that if more than two emails are going back and forth, the writer should pick up the phone. Even an experienced freelance can get the client-management side of the job wrong, and it is the freelance writer's responsibility to take control and manage the clients. The other lessons from that case are these:
- Ask questions; there can never be too many.
- Get all the necessary background materials and project specifications, and put everything in writing.
- Copy everyone involved on all key emails.
- Get people on the phone before emails become too heated or complicated.
- Before getting upset, show the email to someone else, and read emails and comments carefully.
- Never be afraid to apologise and start over.
- Forgive yourself.
Emails can be read in different ways; emotions should not be read into them, and things should not be taken too personally.
A meeting should be made to work. An agenda lets everyone know what is being discussed, and the action items, like the minutes, are distributed within a very short time of the meeting, while everyone remembers what was discussed. Tangents onto items that were not on the agenda go into a parking lot, to be dealt with another day. Where one particular person can solve one particular issue, a meeting with them in advance, before presenting the ideas to the wider meeting, can help. Meetings should not be held for their own sake; in some companies most of most days is taken up with meetings, which is not necessarily productive.
In a knowledge-process outsourcing company, working with clients in different time zones who speak with different accents is a common challenge, and because the relationship with the client rests primarily on virtual communication, extra care with email etiquette and with accent-free English pronunciation is essential.
When what is expected and what is happening diverge
The client, or the rest of the team, should know what is happening, so that they are confident the job is being done properly, and the writer should know clearly from the beginning what the client expects. When what is happening and what is expected are the same, everybody should be happy. When they differ, an effective communication technique such as robust dialogue should be used to solve the problem as soon as it is identified, and hiding one's head in the sand is the worst thing to do while managing a project.
Conflicting preferences or instructions from different people or parts of the client organisation need to be escalated to a higher level, if necessary within the writer's own company, so that the two disagreeing groups can discuss them directly at a higher level and reach a solution. Two groups in a client company with different expectations mean the company has a problem of its own, and it is up to the writer's side to make the company aware of the two agendas.
Rush jobs
A rush project comes in two forms: short notice, where the client expects the project to start right away, and a tight timeline, where the client asks ahead of time but allows only a short time to prepare the document. In either case, the first step is to identify the scope of the project and define what the writer and the client each expect. The scope and timeline of documents vary with the type of document and the client, and these two determine whether a writer can take on a new project. Clear communication, educating the client, and setting expectations and boundaries up front are needed to complete the project to its timeline without compromising quality.
For a freelance, other considerations may include whether the client is new or established, and the time needed to educate them on the process. A rush project from a new client is riskier, because the client may be new to the process in general or to the document type. In one freelance's words, the best asset a freelance medical writer has to offer is their word, and taking on a project that could potentially compromise quality could affect the writer's reputation. Taking the time to educate a new client on how the process might look, set expectations and establish a schedule adds a lot of value, and if the timeline does not allow for this, the client may not be a good fit. In academia, timelines are more flexible for many documents, grant proposals excepted, but expectations still need setting and stakeholders still need educating on the process and typical turnaround times.
The first advice to new writers on a tight timeline is to ask questions: it may slow the process, but it is imperative to get as much information as needed from the client up front, to understand fully the agreements being made and to clarify the deliverables. Another critical piece of advice is to set boundaries. Freelance writers are typically hired to solve problems the client may not have the experience or expertise to solve, and establishing boundaries, such as typical turnaround times and their exceptions, and the expectations of both writer and client early in the process is important. Boundaries are not meant as barriers that hinder progress; they strengthen the collaboration between writer and client and keep the project focused and on target.
When a risk arises that could cause the timeline to be missed, the best strategy is communication, and reaching the project team as soon as possible is critical. That contact is the chance to ask whether the scope of the work is negotiable and whether the document can focus on its key messages rather than the language. If the project team is not providing the information needed for pertinent sections, the principal investigator can be asked for help, for example on whether the timeline can be extended. Proactively setting expectations and keeping communication clear throughout a project can help to keep it on schedule.
Tools that help in writing and editing to a tight timeline include CONSORT guidelines and their extensions for manuscripts; plain-language guidelines such as the Multi-Regional Clinical Trials Center's Clinical Research Glossary, released in June 2021; cheat sheets of client-specific style guides; a second or even third computer monitor; printouts of a grant's request for proposals or request for applications; templates for writers; glossaries from cancer centres or other stakeholders; digitally curated information; time-tracking and management tools; getting more out of software already in use; and checklists and detailed project notes.
Travelling to client meetings
A freelance medical writer may travel, in the UK and abroad, to meetings and conferences with and on behalf of clients, to meetings with established and new clients, and to training courses away from home.
Recording the meeting and staying in touch
A writer taking the minutes of a meeting should take a recorder and spare batteries. Some meetings are recorded or filmed by the client, but the writer's own recording, where it does not breach confidentiality, gives immediate access to what was discussed, and much is missed while scribbling notes. At a conference or meeting where posters and presentations may be photographed, a camera provides a reference for writing the report, again subject to a confidentiality check. Business cards are worth carrying, because networking opportunities arise when least expected, but the client's wishes about handing them out come first: on behalf of an agency for a third-party client, handing them out may be frowned on, so it should be checked first. A laptop with its power cable, a travel adaptor if needed, a web stick and a USB stick keep the writer in touch with their business and give a backup of the meeting documents; the computer should be backed up before travel, the USB stick serves for downloading material given out during the meeting, and mobile phone coverage should be ensured when travelling abroad.
Directions, money and comfort
A writer should know where they are going rather than rely on a client who has made the arrangements and is travelling with them, because a client can pull out at the last minute. Contact details for the client, the people at the venue, the hotel and the travel advisors, directions to the venue, and copies of the travel documents should be at hand. Travelling by car calls for navigational aids, sufficient fuel and change for car parking. Travelling abroad calls for enough currency for transfers and refreshments, even where the client has arranged everything, and for notifying the business credit card provider and the bank. Notification does not always work, as when a card was declined abroad despite it and the bank, being at fault, paid compensation, so a personal credit card is worth carrying as a backup. A spare envelope or folder keeps receipts and expense details safe until the return. Comfortable clothes are recommended for travelling and for any free time. Women may consider wearing flat shoes and carrying smarter shoes in a bag where there is walking or standing around. A book, music or films can help to wind down after a day of meetings.
Working inside a client's team from outside it
Freelances asked in 2016 what challenges and opportunities they found in working within a client's teamwork model, and whether it is easier or harder than working as a full-time in-house employee, gave three answers. One freelance, working 30 to 35 hours a week for an advertising agency with pharmaceutical clients, mainly through each team's project manager or copywriter, found freelancing easier for its flexible hours, absence of commuting and a home quieter than office cubicles. Early on, though, being out of sight meant being out of mind: project managers did not allow enough time for medical editing and then asked for the work to be rushed. Bringing this under control has involved saying yes to rush jobs to earn credibility, even at the cost of weekend work; going into the office about every six months to put faces to names; calling team members to iron out issues that may look testy in email; being courteous in every email; numbering questions in emails so that they are noticed and answered; an order form that prompts project managers for the information the work needs; contacting a project manager a week before a significant or new project to prompt an onboarding meeting; and suggesting project changes that allow more consideration of medical editing. That remained a work in progress, and in this freelance's view project managers appreciate a freelance who works within their teamwork model.
A second freelance held that teamwork is the way to go but harder from outside: an in-house employee is there all the time, known and seen, and knows how colleagues think, whereas a freelance has to work harder to establish and nurture relationships and is not always in touch with the internal politics. This freelance's particularly successful dealings were with teams made up entirely of remote consultants under one project manager outside the company, where nobody had a hidden or political agenda, and in the end the key is a good rapport with the client's team, which depends on the skill and experience of the project manager and on the experts staying on top of the need to communicate.
A third freelance, whose work within clients' teamwork models had until recently meant only uploading and downloading large files from FTP sites, had two projects in two months that required learning very quickly the software the clients used to manage team projects. The more challenging was a regulatory writing assignment, nearly impossible given its scope and timing, for a writing, editing and quality control team of about a dozen people. The client required a client-issued email address that could send only through its portal, input documents came through the portal of the client's client with yet another address, both portals ran SharePoint that had to be learnt at speed, and progress was tracked on a spreadsheet of 18 columns and hundreds of rows across several tabs. Every upload by anyone emailed everyone, so hundreds of deliverables going through about a dozen reviews each produced thousands of notifications, arriving 100 or more at a time, that had to be sifted for one's own documents. The assignment was no easier for the in-house staff, and the freelance nonetheless counted it an opportunity: the chance to be a hero to the client and learn something new while doing important work and being paid for it.
For one experienced freelance, the breadth of topics a freelance covers is one of the most exciting aspects of freelancing, and many freelances write regulatory documents and medical communications content alike, but writers cannot be expert in every area they work in unless they specialise. They can read around a subject and have the background training to understand scientific and medical information, but because they often work with more than one client at a time, they lack the expertise for a product or project that in-house physicians and regulatory and clinical team members have. In this freelance's view, clients should be aware of this, particularly clients who have not worked with medical writers before and who may otherwise think a writer can work in isolation with very little background information. The EMWA guidelines describing the role of medical writers in developing journal articles are, for this freelance, an excellent reference to send such clients, so that they understand the writer's responsibilities and what the writer brings to the project.
Common emergencies
A 2011 conference session on seven emergencies common to medical writing, hosted by one speaker representing the client and one representing the freelance, put each scenario to its audience, who voted on four possible responses.
A new freelance has agreed to a fast-turnaround project for a repeat client in a therapeutic area new to her, and now realises she is in over her head and cannot produce a good draft in the time allotted. The client's speaker would prefer freelances to be honest and straightforward and to discuss the situation, and the audience agreed. Of the audience, 7% would ask for an extension and 7% would write it anyway. The situation could be used as an opportunity to build the relationship with the client, who is likely to be sympathetic if the topic is new to the client as well as to the freelance.
A freelance given four weeks to write a short paper about a congress slide presentation, an easy job of about eight hours, starts three days before it is due and discovers she cannot open the slide presentation. The audience split 74% for coming clean with the truth, 13% for making up a story, and 6% each for enlisting a computer-savvy relative and searching for the slides online. The freelance's speaker would try all four strategies, starting with the relative and the online search, and expected the freelance to have to confess to the client in the end and then deliver a really good article on time. The client's speaker agreed, adding that a writer admitting she had started so late may leave the client feeling the project is not getting enough time and attention.
Across the scenarios, the audience's votes showed that most medical writers have similar strategies for these emergencies, and the discussion showed that their choices are shaped by experience as well as by which side of the paycheck they are on.