"I can read and perfectly understand academic papers in English on a daily basis. However, when it comes to teleconferences with our global HQ, I can't keep up with the pace and end up not saying a word..."
Many talented professionals working in R&D and clinical development at pharmaceutical companies struggle with this gap between their scientific knowledge and their English communication skills.
In multinational pharmaceutical companies, frequent online meetings with global HQ and international branches are unavoidable. Even in domestic Japanese companies, opportunities to use English in a business context are rapidly increasing, such as in discussions with overseas Contract Research Organizations (CROs), out-licensing negotiations, and presentations at international congresses.
In this article, experts will thoroughly explain the crucial differences between academic English and pharmaceutical business English, essential terminology for global clinical trials and regulatory negotiations, and practical phrases for surviving meetings.
1. Is Just 'Reading' Not Enough? The Difference Between Academic and Pharma Business English
The skill sets required for "academic English" for reading and writing papers and "pharma business English" for meetings and negotiations are completely different.
- From One-Way to Two-Way, Real-Time Communication: Academic English, primarily for writing papers, focuses on grammatical and terminological accuracy and logical structure, delivering information in one direction. In contrast, the global pharmaceutical business demands the agility to communicate interactively and in real-time during meetings.
- Silence as a Sign of Disinterest: In business cultures like that of the United States, discussions move quickly, and being silent carries the risk of being perceived as not participating or being uninterested. While many professionals tend to be cautious, failing to actively voice opinions can diminish their influence.
- Compliance-Focused Negotiation Skills: The pharmaceutical industry strictly requires adherence to regulatory authority guidelines, demanding precise and concise language. In a business setting, it's not enough to simply present your own theory; you need the ability to negotiate and discuss by politely raising objections with supporting evidence, such as, "I have concerns about proposal B due to the risk of A."
2. [Definitive Guide] Essential English Vocabulary and Acronyms for Pharma R&D and Clinical Development
Here is a list of common acronyms and terms specific to R&D and clinical development that frequently appear in global meetings and English emails. You need to be able to understand their meaning instantly as they are often used without explanation.
Acronym / Term | English Name | Japanese Translation | Example Usage in a Meeting |
CRO | Contract Research Organization | Contract Research Organization | "The CRO is compiling the data, so we can share the report within this week." |
GCP | Good Clinical Practice | Good Clinical Practice | "Which section of GCP could this change potentially conflict with?" |
IND | Investigational New Drug (application) | Investigational New Drug (application) | "We plan to initiate the clinical trial after IND approval." |
NDA | New Drug Application | New Drug Application | "The NDA submission in the U.S. is scheduled for next year." |
AE | Adverse Event | Adverse Event | "Five AEs were reported during the clinical trial." |
SAE | Serious Adverse Event | Serious Adverse Event | "An SAE occurred, so we promptly escalated it to the safety department." |
KOL | Key Opinion Leader | Key Opinion Leader | "Let's reconsider our clinical strategy after hearing the opinions of domestic KOLs." |
Protocol | (Study) Protocol | (Study) Protocol | "This protocol amendment needs to be submitted to the ethics committee." |
SOP | Standard Operating Procedure | Standard Operating Procedure | "Please perform data entry according to the SOP." |
ICF | Informed Consent Form | Informed Consent Form | "Have you confirmed that all patients have signed the ICF?" |
IRB | Institutional Review Board | Institutional Review Board | "We cannot initiate the study until we receive IRB approval." |
FDA | Food and Drug Administration | U.S. Food and Drug Administration | "The FDA guidance document clearly states that..." |
EMA | European Medicines Agency | European Medicines Agency | "Let's follow the submission format for the EMA." |
PMDA | Pharmaceuticals and Medical Devices Agency | Pharmaceuticals and Medical Devices Agency | "We inquired with the PMDA, and they confirmed that the wording is acceptable." |
ICH | International Council for Harmonisation | International Council for Harmonisation | "We will demonstrate the validity of the analytical method based on ICH guideline Q2(R1)." |
PV | Pharmacovigilance | Pharmacovigilance | "The person in charge of PV will share the latest safety information." |
CTA | Clinical Trial Application (Japan) | Clinical Trial Application | "A CTA submission is required to start a new clinical trial in Japan." |
CRF | Case Report Form | Case Report Form | "Please confirm that the CRFs for all subjects have been collected." |
3. [By Role] English Challenges and Required Skills in R&D Departments
In pharmaceutical R&D, the nature of communication required differs depending on the specific role.
Discovery / Pre-clinical Research
The main arenas are data sharing with international collaborators and presentations at international conferences. The ability to convey complex experimental results in simple English and respond quickly to Q&A sessions is required. Proactively participating in discussions, confidently presenting one's research findings, and engaging in logical debate are key.
Clinical Development / CRA
Daily tasks include progress meetings with overseas CROs, schedule negotiations, and reporting protocol deviations. For tasks like schedule adjustments, polite and non-assertive English expressions such as 'Would it be possible to...?' are required. For matters like protocol amendments, tough negotiation skills are necessary to reach a consensus based on data and regulatory risks.
Regulatory Affairs (RA)
The core work involves preparing submission documents for regulatory authorities like the FDA, EMA, and PMDA, and handling their inquiries. This requires writing skills to accurately interpret regulatory documents from various countries and appropriately cite regulatory language, such as 'We conducted [Y] in accordance with Section X of the guideline.' When responding, it is essential to always provide evidence to prevent misunderstandings with the authorities.
Medical Affairs (MA)
This role involves exchanging information with global KOLs and creating scientific materials. It is crucial to conduct persuasive discussions based on scientific evidence while remaining neutral and unemotional. Advanced facilitation skills are required to explain data based on facts and elicit others' opinions, for instance, by asking, 'How would you interpret these results from a clinical perspective?'
4. Practical Phrases for Surviving Global Meetings (Teleconferences)
Here are some key phrases for professionals to interject, politely disagree, and confirm regulatory details in fast-paced global meetings.
Interrupting Politely
Even in a heated discussion, it's crucial to convey important information, such as safety data. State your point after a brief prefatory remark.
- > “Sorry, can I just add something here?” (Excuse me, may I add something here?)
- > “If I may jump in for a second…” (If I could just interject for a moment…)
- > “Before we move on, may I add something?” (Before we move on to the next topic, may I add something?)
Disagreeing or Stating an Opinion Logically
For proposals that pose a compliance risk, such as moving up a schedule, you should voice your objection respectfully, based on data and regulations.
- > “I see it differently because…” (For [reason], I see it differently.)
- > “That’s one perspective. Another way to look at it is…” (That's one way of looking at it. From another perspective…)
- > “I’m concerned that this approach might pose a risk to safety compliance. How about we instead propose a slight delay and additional review?” (I'm concerned this approach could pose a risk to safety compliance. How about we propose a slight delay and an additional review instead?)
Clarifying Regulatory Nuances
If there is any doubt about the interpretation of FDA or EMA guidelines, ask precise questions to avoid misunderstandings.
- > “Could you clarify if we should interpret Section X of the guideline as…?” (Could you clarify if we should interpret Section X of the guideline as...?)
- > “I’m not entirely clear on how to apply the EMA guideline paragraph Y to our case. Could you elaborate on that?” (I'm not entirely clear on how to apply paragraph Y of the EMA guideline to our case. Could you elaborate on that?)
- > “Just to make sure we’re aligned, does the FDA guidance mean that…?” (Just to confirm we're on the same page, does the FDA guidance mean that...?)
Conclusion: Shifting Your Mindset from 'Passive' to 'Proactive'
In the field of pharmaceutical R&D, your advanced scientific knowledge and deep insights are as good as non-existent if you do not voice them in global meetings.
It is necessary to shift from a passive mindset of simply reading papers to a proactive one of speaking up and negotiating. Even if your English isn't perfect, it's important not to hide what you don't know, but rather to show a positive attitude by saying, 'I will check and get back to you.' Be conscious of participating in discussions confidently while showing respect for others.
"I want practical speaking training for teleconferences with our overseas HQ."
"I want to master tough negotiation phrases for dealing with CROs in global clinical trials."
If you are a professional who wants to rapidly improve not just general English conversation skills, but specifically the 'business English unique to the pharmaceutical industry,' please take advantage of ELT's individual counseling and trial lessons.
