Resolve the comments when reviewers disagree
The functions that review a regulatory document have their own priorities, so their comments on a draft can conflict, and the writer is caught between them. Settling such comments can call for a meeting or call rather than email, an agenda that takes the important points first, a readiness to concede what matters little, and a written summary of what was decided.
Why the comments conflict
Most regulatory documents receive input from different departments, or functions in pharmaceutical jargon, and these functions often have different, and sometimes conflicting, priorities, which may come through in their comments on a draft. Resolving one function's comment may generate a conflict with another function. Medical writers can find themselves caught in the crossfire, and some of these situations can require plenty of tact.
A writer's humorous verse to a client describes comments that undo one another: text the client wanted in the last draft has been taken out and will surely be wanted again; a convoluted sentence the writer adds about the post-text tables for laboratory shifts, which the writer thought sufficient, is then wanted out, and the writer replaces it with the original cross-reference; and the regulatory function has removed pronouns the writer put in for the CRM.
A call or meeting rather than email
As a project progresses, review comments need to be adjudicated and a consensus reached. One regulatory writer's first tip for handling such situations is to organise a teleconference, or a face-to-face meeting if possible. Teleconferences can be interminably dull, but they have advantages. In one regulatory writer's experience, people are more prepared to compromise on the phone than by email, because email depersonalises things and people find it easier to pick an argument with an anonymous string of words on a screen. The words are anonymous because team members in large companies often do not know one another in person, and even where the writer cannot put a face to the voice on the phone, the level of human interaction on a call is higher. After a couple of hours on a call, when fatigue is setting in and the end of the scheduled slot is approaching, people may soften their views, whereas email exchanges are open-ended, and people can come back to them with renewed vigour after lunch, the next day or whenever. Email does have the advantage of leaving something in writing.
A meeting or conference call is sometimes, but by no means always, an efficient way to adjudicate comments, especially if it enters a kind of brainstorming dynamic. On other occasions, prolonged arguments about minor points lead to an unproductive meeting. A well-prepared hierarchical agenda can help avoid this by ensuring that points are addressed in descending order of importance.
Negotiation and concession
When two headstrong participants have differing opinions, reaching a successful outcome often involves compromise and negotiation. Ideally the writer has already formed an idea of who is going to be stubborn and who reasonable. To move things forward, the writer often has to make a concession to some of the participants, and finding an appropriate one may require a certain creativity and perhaps a certain Machiavellian streak.
The same writer thinks that, as in any negotiation, it is important to show a spirit of compromise: most people are keen to move on, so if offered something they will usually be prepared to budge from an entrenched position. It also helps to save time and energy for the things that really matter. When a reviewer insists on hyphenating a certain compound noun, the writer can probably safely let it go, but a reviewer who insists on omitting a piece of information the writer judges important, on the writer's interpretation of applicable guidance for example, is another matter. Deciding what is important and what is a distraction is where experience comes in. Experience also helps because a more expert writer is more likely to command respect, which makes it easier to browbeat dissenters within the team.
Soft skills can be important for resolving conflicts in review rounds, and some people are inherently more gifted in them than others, but the skills can be acquired to a certain extent through experience.
A summary of what was decided
If important decisions or agreements have been made, it is often helpful to send the participants a summary of them soon after the meeting, while it is fresh in their minds; this will usually not have to be formal minutes. After a teleconference, it is useful to jot down minutes summarising what was decided, even very high-level ones, and to distribute them to the participants. The summary ensures that the writer's understanding of what was said is aligned with the others', as interpretations of the same meeting can vary greatly. It provides a written record that avoids revisionist interpretations of the decisions made. It is also a record of the decisions or agreements should a blame game begin later, after problems emerge in a project that are not necessarily anyone's fault.