From vendor to trusted partner
A writing vendor, such as a contract research organisation's regulatory writing group or a writer working for a sponsor, turns a transactional relationship with a pharmaceutical company into a partnership by having the right capabilities in place, avoiding what makes such relationships fail, stating and improving the value it offers, handling the disputes that strain the relationship and a lost client's confidence, and bringing the project management the sponsor now expects. The value proposition is stated inside an in-house department and a freelance practice too. Choosing between the two sides as an employer is in writing for a pharmaceutical sponsor or a CRO, keeping an individual client in what keeps a client coming back, ending a relationship in when a client relationship fails, and leading a team without managing it in leading a project team as the medical writer.
Know what the relationship is worth and why it fails
The account of the vendor's side is a vendor executive's, responsible for regulatory writing, strategy and operations teams, given in a 2021 journal interview that followed his conference talk of May 2021 on overcoming a challenging sponsor. A successful relationship between a contract research organisation and a pharmaceutical company assures and accelerates regulatory success, and a failed one delays approval and costs the company money by shortening the product's time on the market. The Winter 2021 AMWA Journal issue (volume 36, number 4) was converted from its PDF by layout-aware Poppler XML conversion and admitted without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated.
Five components of the vendor's regulatory process have to be fully in place, with the people and technology to support them. Regulatory and medical writing, by writers experienced in every document type for the major agencies in the Common Technical Document format, using technology that drives efficiency, accuracy and speed and manages documents across their life cycle. Regulatory consulting and affairs, providing a robust development and submission strategy, a gap analysis, expedited pathways for urgent documents and an integrated global strategy so that content from the primary submission can be reused in other markets. Regulatory operations, submitting compliantly through simplified review, proactive management of timelines and deliverables, and electronic CTD delivery in every therapeutic area. Regulatory technology, using artificial intelligence to map clinical data to templates and automate document development. And transparency and disclosure, including AI-powered anonymisation and redaction, trial postings and results disclosure, plain language summaries and patient engagement strategies. A small organisation that cannot afford all five, the technology especially, can instead aim at operational excellence and raise its profile through consistently high-quality writing and regulatory affairs work.
Four of the primary reasons such relationships fail are a document delivered late against the agreed timeline; a document of poor quality that misses expectations or industry standards; a missed return on investment, when the cost of the deliverable does not match the value the sponsor perceives; and a failure to address continuing performance concerns within the relationship.
Leaders of medical communication agencies who met in 2015 named four further areas where agencies could act together, without prioritising them. Sharing best and worst practices for bringing a new agency on board, drawing on years of agency experience across many clients and on having been clients themselves, with input from industry clients on how agencies should prepare for onboarding. Finding efficient and cost-effective ways to meet rising client-driven compliance training, including reducing redundancy among client training programmes through some standardisation. Explaining the role and value of agencies to the audiences that need convincing — industry clients with limited experience of outsourcing publication planning and delivery, critics who judge the whole sector by the poor practices of a few, and agencies that undermine the sector's professionalism through inappropriate terminology on websites or in recruitment advertisements or by declining to commit to ethical publication practice guidelines. And developing guidance on conflicts of interest: how different clients and agencies define a conflict, the commonest stipulations in confidentiality agreements, how long after a conflict ceases work should be declined, and what counts as best practice for firewalls when a single agency network separates conflicting work among its divisions.
State the value, and improve it
The vendor shows its value through a unique value proposition: a focused, easily articulated statement of the benefits it provides and why they matter to the sponsor, which requires understanding the sponsor's challenges and how the service meets them, presenting the differentiators that set it apart from other vendors, and crafting a message that demonstrates the value of the solution. For an individual writer, improving it means a regular 360-degree review that includes a self-evaluation; one or two areas of technical skill, knowledge, ability or competency chosen to improve each year; a fee commensurate with the quality of the service and the writer's experience; and looking for ways to innovate, such as technology that improves the quality and efficacy of documents. Jim Collins's Hedgehog Concept, from Good to Great, puts the target where three circles meet: what the writer can be passionate about, what the writer can truly excel at rather than merely be good at, and what drives consistent, reliable capital and profitability.
The partnership rests on TRUST, the outward expression of the value proposition a vendor brings: technical competency, the knowledge and skills to complete the deliverable; reliability, trustworthiness and consistent performance; unity on purpose, understanding of and alignment with the sponsor's goals; service orientation, priority to the sponsor's needs and excellent customer service; and transparency, discussing any issues and advising from experience. Moving from a transactional relationship to a strategic partnership takes three things: managing projects effectively, creating and delivering on the value proposition, and establishing value through TRUST.
Handle the disputes that strain the relationship
The first dispute is a sponsor that hires a vendor for its expertise and then overrides it. A company hired a vendor for its therapeutic expertise and its experience with the FDA's Office of Rare Disease, Pediatrics, Urologic, and Reproductive Medicine, then, desperate to be first to market, asked it to write the summary of clinical safety and the integrated summary of safety for a new drug application with one year of data, although FDA guidance suggests at least two years of pivotal safety data — putting the application at risk of rejection. The vendor should share its concerns and prior experience transparently, make sure they reach the key stakeholders, document the risks and mitigation strategies in meeting minutes, and then stay motivated and show its expertise by delivering a quality document.
The second is a timeline dispute. The contract for a pivotal study's clinical study report, on the critical path to the application, provided for two drafts and a final, but the tables, listings and figures would not be available until the final draft; their late delivery compressed the final report's timeline, left little time for a full quality-control review, and protracted the review cycle as new reviewers and stakeholders joined. Missing timelines or delivering poor quality damages long-term credibility and goodwill, so the writer, and the project manager if there is one, should push back: explain the consequences of the shortened review cycle and of changing reviewers and stakeholders, negotiate a realistic timeline together with the sponsor, build a shell report from draft or placeholder data and get it approved against the agreed template, identify quality risks and their mitigation up front, and use online review technology such as PleaseReview followed by comment-resolution meetings.
The third is lost confidence. After a long consulting relationship, a few projects went badly and were pulled back in house, and a change of leadership at the sponsor left the vendor relatively anonymous to the new leaders, so the outsourced work declined. Confidence can be lost overnight and takes a long time to regain: review the performance feedback, develop a corrective action plan, collaborate on the lessons learned and take accountability; offer concessions such as a lower rate or credit against future work; accept that a cooling-off period may be necessary; and rebuild credibility by completing lower-complexity tasks successfully.
Bring the project management the sponsor expects
Sponsors increasingly expect writers to take a leadership role in the submission team, which makes upskilling in project management critical: communication, teamwork, analysis, planning, budgeting, goal setting, understanding risks, problem solving, meeting deadlines and reaching milestones. Writers should know two versions of the project-management triangle. In the first, a project is bounded by time, cost and scope, and changing one forces an adjustment of the others — an expedited timeline raises the cost because more writers are allocated — with quality the factor every change puts at risk; in the second, quality becomes a fourth constraint and customer satisfaction the measure of success, a project succeeding by meeting or exceeding the sponsor's expectations. Building credibility in a new team and leading without authority are in leading a project team as the medical writer.
State the value from inside a department or a freelance practice
The value proposition in the other settings a writer works in comes from a 2021 conference panel of writers whose experience spans a freelance business, a small vendor business and department leadership in biotech and large pharmaceutical companies, published in 2023 as the first part of a three-part series with some of the session's text paraphrased for clarity in print. The Summer 2023 AMWA Journal issue (volume 38, number 2) was converted from its PDF by layout-aware Poppler XML conversion and admitted without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated. A value proposition is the idea that a service or product is attractive and valuable to a customer or end user, and an in-house regulatory writing department's, in brief, is that it develops documentation to support the research and development objectives of a much larger organisation. One writing firm states its own as applying years of experience and current regulatory and technical knowledge to help deliver important new therapies to patients expediently, as a best-in-class firm proud of its operational excellence, and breaks the term into four parts: what the firm uniquely brings to the table, what it stands for, what challenges it solves and what gains it offers, the aim being that a customer chooses it, keeps coming back, and sees it as the go-to to get things done. The idea translates to the in-house setting. The goal is the same whether the writer is independent or in-house — an excellent product for the client, which for an in-house writer is the clinical team or the document development team. For a freelance the value proposition is problem-solving: clients come to a freelance when nobody on staff, and no freelance they already use, can do the job, so the task is to understand what is driving the client's need, to give the client confidence in the freelance, and to make the client's job easier.
Keeping that value visible is a matter of trust. One firm's writer enters every client relationship expecting to keep proving herself — not only that her firm can execute a clinical study report but that it can execute a supplemental new drug application in its entirety — because needs, requests and the regulatory environment change. With one client whose funding situation produced questions about every dollar and cent, she walked the client through what goes into the work, how many hours a given document takes and every step in it; the questions fell away and the tone shifted to a more trusting partnership, so a difficulty with the value proposition is worth a conversation. Trust and confidence therefore belong in a business plan, although they are not usually thought of that way. Clients often do not realise how much easier a freelance makes their jobs by anticipating where other freelances go wrong — not staying in touch or on top of projects, calling at the last minute to say they are behind — mistakes that are easy to avoid with attention; one freelance's proof was a client's email telling him he was everything someone else had said he was. An in-house writer faces the same test, being only as good as the last document. The problems solved may differ, such as navigating complex internal processes for the team or tracking the regulations most relevant to it, but quality is expected all the same, and because everyone learns to write but not everyone writes the way a given document or audience needs, part of the job is educating the team, treated as the client, about what the work involves and the nuances of the craft.
The panel's second part, published in the Winter 2023 issue, turns from value to communication, leadership and corporate responsibility, again with some of the session's text paraphrased; two of the panellists worked in-house at a pharmaceutical company. The Winter 2023 AMWA Journal issue (volume 38, number 4) was converted from its PDF by layout-aware Poppler XML conversion and admitted without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated. Communication is a writer's stock-in-trade, and yet it works differently in a business context, where it makes or breaks a writer wherever they sit. A writer who can explain clearly what they do has set the baseline for any conversation, and inside a team the writer has to explain what they bring, why, and what the team needs to know. One practice is to answer the team's questions before they are asked, anticipating what is coming and having a contingency plan, so that the team, as the client, senses that the writers have been there before. That takes away tension that need not be there, and where a project is new to everyone, saying so up front — the writers know how to write the document but need to learn some things from the team, and have to work together with it — keeps the same transparency. The writers are the document development experts, and their job is to let team members concentrate on their own expertise without worrying about the document; because everyone learns to write, team members think they are the writer and may need to be kept in their swim lane.
Making the writer's case to a different listener can take translation. In one in-house writer's meeting with a senior regulatory person and a company president with an MBA's focus on return on investment and very bold goals, describing the way narratives are done as "the industry-standard way of doing this" turned out to be a phrase that tended to make the president's head explode. The regulatory leader rescued the exchange by asking which parts of the process could be broken down, which had to stay as they were to maintain quality, and where the team could be bolder. Someone a writer can observe, who can model how to translate a medical writing argument into terms that make sense to a person focused on return on investment, is critical, and the mentor need not be in medical writing at all: a senior leader in regulatory or another adjacent function can do it.
For a freelance, three communication areas matter most. Responsiveness comes first: worse than a client hearing nothing about a new project is a client hearing nothing in the middle of one, so a reply should come almost immediately, even if only to say the message has arrived and an answer will follow. Confidence is the second — speaking the language of the project so the client moves past whether the freelance can do the job to getting the freelance the information needed to do it. Frankness, the third, benefits the freelance rather than the client: staff people do not think about the business the way freelances do, so it helps to explain in plain terms why things work differently for a freelance, with pricing by the project as the example.