A medical writing survey was conducted by Emtex Life Science to reveal the most common challenges among medical writers. This report summarizes the findings from that survey. We have also included tips from Emtex Life Science medical writers on how to overcome these challenges.
The survey was distributed among medical writers and professionals who collaborate with them. | |
Commonly reported obstacles have been summarized for each challenge in the “Respondents’ Insights” section. | |
Emtex Life Science medical writers have provided tips and tricks on how to overcome the challenges. | |
The most requested training topics among respondents are listed at the end of the report. |
Emtex Life Science – Medical Writing Survey Results
WHAT IS MOST CHALLENGING IN MEDICAL WRITING?
Challenge 1: Managing Tight Deadlines to Finalize Documents in Time
RESPONDENTS’ INSIGHTS
External factors: client and regulatory constraints: Unrealistic deadlines set by clients or notified bodies, along with late involvement of medical writers and delayed reviews and approvals, create pressure and reduce time for document preparation. Regulatory teams often delay document finalization, causing last-minute rush.
Resource and workload management: Medical writers face challenges with meeting deadlines due to understaffing, resource constraints, and multiple projects running simultaneously. Managing different stakeholder expectations and extensive revisions due to multiple feedback cycles often also lead to after-hours work.
Internal workflow and planning: Tight deadlines, poor planning, last-minute document initiation, and late data or document delivery from stakeholders lead to compressed writing time. Last-minute changes, unexpected revisions, and crossfunctional dependencies further disrupt timelines and increase workload near deadlines.
Quality versus speed trade-offs: Late-stage changes and tight deadlines increase the burden on medical writers to rewrite sections quickly and make it difficult to ensure document accuracy. Errors may arise due to limited time for reviewing and quality control.
TIPS FROM EMTEX MEDICAL WRITERS
Plan ahead: Being well prepared prevents a lot of stress. Plan sufficient time and flag time issues early. With a well-ordered planning, you’ll feel confident and prepared. If you don’t have time to take in another project, don’t be afraid to say no. It’s in the interest of both parties. If you flag it early,
other resources can be sought.
Schedule time for unexpected tasks: Most things don’t go as planned. Allow yourself some flexibility by actively scheduling time for unexpected tasks. This time is never wasted. If you have time at the start of the project and you know deadlines will get tight later, begin early to spread out the workload.
Communicate and solve issues together: You’re not in it alone! Communicate with the team when time issues occur. Don’t just flag the issue, propose possible solutions. Ask about their priorities and inform them of what’s possible from your side. With combined efforts, you will find the best solutions.
Reach out for help and help others: Even the best planner’s schedule gets messed up once in a while. Reach out for help. Together, you can handle it! Offer help where you can and they’ll return the favor. Fundamentally, the overall workload should be manageable, and it’s unlikely that everyone will be overloaded at the same time.
Don’t compromise on quality by hastening: No one gains by rushing things and delivering half work. Calm down, breathe, and continue with the same standards like you always do. You got this! A delay of an hour or two (or even a day) is better than providing inadequate services.
Challenge 2: Coordinating Diverse Teams and Stakeholders
RESPONDENTS’ INSIGHTS
Time and scheduling: Tight timelines and busy schedules make it difficult to receive feedback in time. Finding an ideal timeslot for scheduling meetings with all teams involved or with global teams in different time zones is challenging.
Communication and collaboration issues: Engaging teams to fulfill their responsibilities, provide concrete feedback, and adhere to timelines is challenging. Lack of clear communication, misaligned priorities or availability, and people giving confusing comments instead of suggesting concrete improvements, create misunderstandings.
Stakeholder dynamics and team coordination: Teams that don’t work well together require project management to ensure the document progresses. Different workflows among teams, decision-making processes, expectations, priorities, varying levels of understanding, and inflexible rules can cause difficulties.
Practical difficulties: External stakeholders often have no access to the platform used, leading to difficulties in combining and aligning comments. Coordination is complicated when there is a lack of centralization of writing efforts, when stakeholders have different and busy schedules, and when teams are unaware of how their input fits into the larger process.
TIPS FROM EMTEX MEDICAL WRITERS
Use technology for communication and collaboration: Leverage centralized platforms, such as shared document systems, project management tools, and communication platforms, to streamline feedback and collaboration. These can help address challenges like varying time zones, different schedules, and multiple reviewers.
Set clear expectations and deadlines: Establish clear timelines, quality standards, and expectations from the start. Set realistic deadlines and allow buffer time for unexpected delays. Regularly track progress and provide timely reminders to ensure deadlines are met. This can help avoid delays and keep the project moving forward.
Focus on key experts: When dealing with many stakeholders or large teams, ensure that the appropriate experts are involved at each stage of the process and provide their input at the right time.
Be flexible and manage team dynamics diplomatically: Recognize that diverse teams may have different communication styles. When managing different stakeholder opinions, keep an open, collaborative approach. Be flexible in adjusting timelines or processes to accommodate different team dynamics and if necessary, schedule oneon-one conversations to address conflicts or misunderstandings.
Define roles and responsibilities: Clearly define the roles and responsibilities of each team member and stakeholder to ensure everyone knows their specific task, how they contribute to the project, and to prevent overlapping duties and confusion.
Challenge 3: Handling Large Volumes and Complex Documents
RESPONDENTS’ INSIGHTS
Volumes and complexity of data: Handling clinical documents, especially in late-phase studies and regulatory submissions, is challenging due to complexity, consistency, and organization. Managing numerous reports, frequent updates, and large datasets can complicate decision-making and prioritization.
Timelines, deadlines, and resource management: Time constraints, limited resources, the need to implement numerous comments quickly, and the pressure of reviewing extensive literature or handling multiple projects simultaneously add to the difficulty. System limitations and outdated data formats can further complicate the process.
Data organization, quality, and analysis: Organizing, focusing on audience, condensing information, maintaining version control, and handling literature review are challenging when handling large volumes of data. The many documents to read and understand, and the decision which references and analyses are most relevant can be tough.
Consistency: Maintaining consistency in the narrative while integrating data from various formats, such as charts, tables, and raw figures can be particularly tricky when working under tight deadlines or collaborating with multiple stakeholders who may have differing expectations about what data should be emphasized.
TIPS FROM EMTEX MEDICAL WRITERS
Effective data management: Employ specialized writing tools, such as reference software (EndNote or Zotero) and spreadsheets, to organize your sources and to manage data. This allows to track references, ensure consistency, and access relevant information quickly.
Careful organization: Organize your data and document from the start. Divide data into logical
categories or folders so you can easily find back all information. Create a structured outline for the entire document to guide your writing and to ensure a logical flow of your writing, with headings and subheadings.
Prioritize key information: When dealing with large volumes of data, focus on the key takeaways for the target audience and prioritize the client’s requirements. It’s essential to agree on the key messages upfront to ensure consistency throughout the document. Stay detail-oriented but keep the overall purpose in mind.
Break workload into manageable chunks: Break down the writing process into smaller tasks and set deadlines for each task to avoid overwhelming yourself later and to ensure steady progress. This also benefits stakeholders by allowing regular progress updates and quicker feedback.
Version control and document tracking: Use version control to track changes and updates to your document, especially when working with multiple revisions or collaborators. Tools like Microsoft Word’s track changes allow efficient tracking and managing edits, ensuring you don’t lose important information.
Challenge 4: Understanding and Adhering to Regulatory Requirements
RESPONDENTS’ INSIGHTS
Complexity and vague guidelines: Regulatory guidelines can be unclear, vague, and subject to interpretation. Templates may not always provide enough detail or clear guidance.
Constantly changing requirements: Staying up to date with constantly evolving regulatory requirements is a significant challenge. This includes keeping track of updates and modifications and adapting to different jurisdictions. The client guidelines and templates can be contradictory, flawed or against best practices.
Regional and jurisdictional differences: Each country or region has its own specific regulatory requirements, classifications, and processes, which often don’t align with each other.
Collaboration and communication: Lack of support from regulatory team members, along with difficulties getting team alignment, and disorganized teams and companies are additional complicating factors.
TIPS FROM EMTEX MEDICAL WRITERS
Keep up with regulatory updates: Stay up to date with regulatory requirements (eg, EMA, US FDA, ICH). Plan weekly or monthly timeslots to check for and familiarize with regulatory updates. Alternatively, you can find all key updates in the field of medical writing conveniently summarized in our monthly Emtex Life Science newsletter.
Provide adequate training opportunities: Follow training sessions (eg, EMWA, AMWA) or consult publications like the new ICH E6 (R3) to better understand content requirements. If possible, request examples of similar regulatory documents meeting the requirements. Consider designating a champion for each document type to ensure consistency and expertise.
Bridge gaps in guidelines between authorities: Develop a master checklist that includes common requirements across multiple regions. Authority-specific templates or checklists that adjust based on the specific authority (FDA, EMA, etc.) can also be helpful, if available. For further guidance, refer for example to the Core Reference Project or TransCelerate.
Foster collaboration: Be clear about the support you need from the regulatory team. Joint meetings where everyone can share insights and clarify expectations, as well as clear, standardized templates, can also facilitate team alignment and an organized workflow.
Seek advice from regulatory experts: It’s important to recognize that as medical writers, we focus on content requirements, not regulatory expertise. Stay informed by regularly consulting reliable sources but also recognize the value of seeking help from regulatory experts when needed. Medical writers act as a bridge, connecting the clinical data with regulatory requirements.
Challenge 5: Creating Set of Documents for Regulatory Submissions
RESPONDENTS’ INSIGHTS
Team dynamics: Submission experience varies across teams, making it challenging to communicate concepts effectively. Medical writers with limited experience may require time to get up to speed and create lean, high quality documents.
Complex and evolving regulatory guidelines: Difficulties arise from the complexity and specificity of the regulatory guidelines, which are sometimes unclear, not specific enough, or subject to frequent changes. It can also be challenging to understand the full picture of requirements across different countries. The need to compile large volumes of data can be overwhelming.
Variability in expectations: The requirements from notified bodies vary depending on the reviewer. The content often needs to be adjusted to fulfill subjective interpretations of the regulatory guidelines, leading to frustrations. Each client has a different perspective on which documents should be included, adding another layer of complexity.
Document complexity and specificity: Obtaining all source documents on time can be challenging, especially when dealing with data from previous studies (same compound/indication).
TIPS FROM EMTEX MEDICAL WRITERS
Get a clear plan: To avoid the issue of jumping ahead, it’s important to establish a clear plan that outlines the necessary steps and timeline for completing each document. This includes ensuring that everyone on the team agrees to follow the plan so the process flows smoothly. Also use available tools,
templates, and guidelines for efficient document preparation.
Effective teamwork: Successful collaboration is crucial, especially when multiple documents need to be finalized simultaneously. Establish clear communication channels with your team, especially with regulatory affairs colleagues. Regular check-ins and collaborative planning can prevent bottlenecks
and improve overall efficiency.
Master regulatory guidelines: Thoroughly review the regulatory guidelines and seek clarification when needed. Leverage available resources, collaborate with subject matter experts, and ensure compliance within and consistency across regulatory documents.
Focus on source documents before summaries: Ensure the team prioritizes the preparation and completion of the source documents first. Without these primary documents being finalized, the summary documents can’t be accurate or complete. It’s crucial that timelines are respected to allow sufficient time for the later documents.
Continuous learning: As you gain experience, you will naturally become more comfortable with regulatory documentation. Seek opportunities for hands-on involvement, shadow experienced colleagues, and look at documents across different domains as examples to broaden your understanding.
Challenge 6: Ensuring Accuracy and Clarity of Medical Content
RESPONDENTS’ INSIGHTS
Simplifying complex concepts when faced with unfamiliar topics: Medical writers are trained to make complex ideas simple and easy to understand. This can be challenging, especially when faced with unfamiliar disease areas, as they are not subject matter experts and must quickly grasp new concepts. Even with proper training, balancing accuracy and simplicity remains difficult.
Conflicting input from stakeholders: Medical writers may work with team members who have differing opinions, unclear expectations, or provide feedback that is not always accurate. This makes it hard to understand what is needed and adjust the document properly. The challenge lies in ensuring that the content is accurate despite these issues.
Data verification and consistency: Ensuring data verification and consistency is challenging with multiple source documents or tight deadlines. Changes during the writing process can complicate source tracking. Updating multiple documents simultaneously also requires addressing inconsistencies to maintain accuracy across all materials.
Clarity and conciseness: Clarity and conciseness are difficult in medical writing, especially when the target audience or study purpose is unclear. Too much information and complex data can make it hard to highlight the key points. Working on a document for a long time can also make it harder to spot areas that need more clarity.
TIPS FROM EMTEX MEDICAL WRITERS
Focus on the core message: To ensure accuracy, focus on the key takeaways and topline results. These can help you understand the main messages. Additionally, a presentation from the core team (including clinicians and statisticians) can provide clarity on what is important.
Engage early and regularly with the review team: Start with a kick-off meeting to align goals and expectations, setting a strong foundation for the project. Work with experts like statisticians and clinicians to ensure scientific accuracy and comprehensibility. Regularly review and validate content with these experts.
Ensure quality control: Quality control (QC) means checking if a document is clear, accurate, well organized, and consistent. At Emtex, QC is performed by the document writer throughout the document development process and by an independent writer before finalization. Our QC process is guided
by a standard operating procedure and QC checklists.
Simplify writing: Lean writing is a clear and concise writing style that eliminates all unnecessary elements for the audience and keeps the message to the point. Everything that is not needed should be eliminated: avoid repetitive text, use cross-references rather than a repeat of information within or across documents, and try to cut down as much as possible.
Put yourself in the shoes of the reader… is it clear? Think about the reader’s perspective to ensure clarity. Provide enough detail to answer questions before they arise. This makes the content easier to understand and reduces the need for clarification.
Challenge 7: Managing Resources to Fulfill Medical Writing Needs
RESPONDENTS’ INSIGHTS
Resource availability: Medical writers often face challenges with limited internal teams and tight budgets. They must manage resources carefully, juggling multiple projects with shifting deadlines. This can lead to delays and quality compromises when urgent tasks arise.
Workload fluctuations and project management: The workload in medical writing can vary significantly, with periods of low activity followed by intense spikes in demand. Unexpected regulatory delays or shifting timelines often disrupt project schedules, requiring teams to quickly reorganize. Managing multiple projects with changing deadlines and complex demands makes coordination difficult and can lead to strained resources.
Team and skill set challenges: Medical writing requires a wide range of skills. With limited staffing, it can be challenging to match the right skills to each project. Furthermore, some contributors may not fully understand the requirements of specific medical writing tasks, leading to gaps in quality or missed expectations.
Budget, planning, and organizational issues: Budget limitations often restrict access to the necessary resources for medical writing. Delays in approving budgets and lack of specialized tools can cause disruptions. These issues make it difficult to meet deadlines and maintain quality.
TIPS FROM EMTEX MEDICAL WRITERS
Align workload with team capacity: Effective medical writing team planning starts with setting clear goals and deadlines for each project. Regularly schedule team meetings to discuss progress, address challenges, and ensure alignment. Also, avoid disconnecting the current workload from the team’s actual capacity to ensure realistic expectations.
Manage changes to the timelines: When timelines change unexpectedly, it’s crucial to stay flexible and proactive. Reallocate resources and adjust workloads to meet the new deadlines, possibly bringing in additional support if needed. Schedule frequent check-ins for challenging projects to monitor progress.
Implement peer review: Implement a peer review system to maintain high standards by allowing experienced writers to provide feedback on documents from more junior writers. Provide a checklist to review the text flow, clarity, and completeness of the document.
Build the right team for the project: Always aim to find the most suitable person for the project. If specific experience is required but not available, consider pairing a writer with related experience with someone who has the relevant expertise to provide support and guidance. This approach ensures the team has the right skills while maintaining flexibility.
Help medical writers expand their knowledge: At Emtex Life Science, each new medical writer receives support to help them navigate their role and environment. More experienced colleagues provide guidance and share their expertise. To foster development, junior writers are also given opportunities to handle smaller, simpler tasks to build their confidence and knowledge.
Challenge 8: Receiving Budget Approval to Get Medical Writing Support
RESPONDENTS’ INSIGHTS
Budgeting and resource allocation: Medical writing is often not prioritized, leading to underfunded projects. Clients underestimate the time and quality needed, resulting in budget overruns. This causes delays and additional costs due to insufficient initial budgets.
Communication and client expectations: Poor communication can delay budget approval and affect timelines. Clients often don’t understand the time or expertise required, which leads to misaligned expectations. This increases costs and extends project timelines.
Market and competitive pressures: Agencies competing for projects often underprice, putting pressure on medical writers. Clients expect high quality but hesitate to allocate sufficient resources. This leads to undervalued work and lower compensation for writers.
Time management and workload distribution: Managing medical writing within tight deadlines is challenging with limited resources. Some companies can allocate extra help, while others struggle to balance quality and timelines. This can lead to overburdened teams and reduced work quality.
TIPS FROM EMTEX MEDICAL WRITERS
Establish clear expectations early: It’s crucial to understand client’s expectations from the outset, including the specific role they expect from the medical writer. Define the scope of the project and deliverables. Clearly outline the specific tasks, time needed, and expertise required for the project, providing a detailed rationale for why the budget is necessary.
Develop a detailed budget: Develop a detailed budget that includes realistic estimates for time and
resources required at each stage of the project. Be transparent about the risks of underfunding, such as project delays, compromised quality, or increased costs later on.
Emphasize the importance of high-quality writing: Help clients understand that investing in high-quality medical writing can prevent regulatory setbacks. Good source documents lead to accurate
summaries, reducing follow-up questions from regulatory authorities. Medical writing is a specialized skill that allows other team members to focus on their core tasks.
Communicate clearly throughout the project: Stay in regular contact with clients, project managers, and writers to keep everyone updated on progress, timelines, and any issues that arise (and may increase initial budget). This helps prevent misunderstandings and ensures everyone is on the same page throughout the project.
Negotiate the budget: To negotiate the budget effectively, implement the earlier tips by clearly defining the project scope, tasks, and resource requirements. Communicate openly with the client to manage expectations and align on deliverables, while ensuring the workload is balanced for successful
project delivery.
Challenge 9: Communicating Scientific Concepts to Non-experts
RESPONDENTS’ INSIGHTS
Simplifying complex information: A key challenge in medical writing is turning complex scientific terms into clear and simple language. It is important to keep the information accurate while making it easy for a wider audience to understand. Striking the right balance requires careful attention to detail.
Adapting to audience needs: Medical writers must adjust their writing to fit different audiences, each with varying levels of expertise. Finding the right level of detail for each group can be difficult. Conflicting expectations from stakeholders can add to this challenge.
Resource limitations: Limited resources, such as lack of expert input or clear references, can make simplifying complex content harder. Without sufficient guidance, writers may struggle to make information clear without oversimplifying it.
Communicating technical concepts: Explaining complex scientific concepts in simple terms can be difficult, especially when the content is highly specialized. It can be challenging to maintain clarity while ensuring key details are not lost. This is particularly important in documents aimed at a lay audience, such as informed consent forms and lay summaries.
TIPS FROM EMTEX MEDICAL WRITERS
Know your audience: Understanding your audience’s background and level of knowledge is crucial for effective communication, especially in fields like pediatrics where a child’s developmental stage should be taken into account. Try to engage the reader by telling a story.
Use clear, concise language: Make the document clear by using simple sentences, consistent terms,
and avoiding jargon or excessive abbreviations. Create a glossary of key terms with simpler definitions and include relatable examples to make the content more accessible. Ensure correct grammar, spelling, and a readable font size for better understanding.
Keep it short and structured: Structure the information using headings and bullet points. Break down complex procedures into simple steps. Reduce unnecessary text by rereading and editing for clarity and conciseness.
Visualize the concept: A well-designed visual can often explain more in a few seconds than a paragraph of text. Adding a diagram or chart to an informed consent form can help potential participants understand the (often complex) study design and visit schedule of a study.
Test the readability: Read your document aloud and imagine you’re the reader. Readability tools can help assess the reading level, but keep in mind that they measure the word and sentence length rather than the actual context. Get feedback from non-scientists.
What Type of Training Would Help the Respondents Overcome the Challenges They Face in Medical Writing?
The respondents provided feedback on the trainings they would be interested in attending. All feedback is ordered into categories and presented below
| SCIENTIFIC WRITING | COLLABORATION AND STAKEHOLDER MANAGEMENT |
| • Writing clear, concise, and scientifically accurate documents • Lean writing techniques • Guidance on translating scientific data into summaries • Advanced scientific writing and data interpretation • Creating documents for various audiences (eg, public communication, regulatory bodies) • Advanced technical skills (eg, statistical analysis, technical writing) | • Improving communication within teams (internal/external) • Stakeholder management and negotiation skills • Strategies for engaging clients and releasing resources on time • Coaching on managing difficult stakeholders and project conflicts • Networking, soft skills, relationship building |
| AI TOOLS AND TECHNOLOGY | PROJECT AND TIME MANAGEMENT |
| • AI tools for managing resources and document checks • How to leverage AI for mundane tasks to improve efficiency • Familiarity with technology tools that support regulatory document creation • Templates and tools, such as advanced Word training | • Flexible workflows and strategic changes • Time management training (eg, creating outlines, reviewing references efficiently) • Managing large volumes of data and evolving demands • Creating efficient documents |
| HANDS-ON AND PRACTICAL TRAINING | REGULATORY KNOWLEDGE AND COMPLIANCE |
| • Real-life case studies and hands-on experiences • On-the-job training like shadowing senior medical writers • Exposure to multiple projects to gain practical experience | • Stay updated on changes in regulatory guidelines and requirements (eg, ICH, FDA) • Country-specific regulations and guidelines • Regulatory documents and submissions, including CTD and IND • Clinical trials and pharmacovigilance training |
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