A pharmaceutical technical writer prepares medical documentation such as instruction guides, precautions for medications, manuals, and reference guides.
Pharmaceutical and technical document writing is a specialized field. It requires much more attention to prepare complete pharmaceutical documentation in comparison to writing any generic SOP document.
Chemists and engineers usually find it challenging to write tech documentation, and the same is true for biologists and microbiologists. The dire requirement for medical research documentation mirrors the need for technical writers in the pharmaceutical industry.
According to Glassdoor’s salary estimate, a pharma technical writer earns an average of $82,911 per year. According to different companies, the salary ranges from $52K to $133K, with an average of $82K.
In this article, we will look up the duties of the pharmaceutical technical writer. Let’s dive right in.
Pharmaceutical Technical Writing: Role and Responsibilities of a Writer
A pharmaceutical tech writer leads and handles the development of technical documentation in a pharmaceutical company. In the highly regulated pharma and biotech industries, effective technical writing is crucial for adhering to GxP quality guidelines and regulatory documents, ensuring the safety and efficacy of products. Companies often face challenges in finding employees who offer technical writing skills combined with skill and content knowledge, making it essential to emphasize the critical role of technical writing in the pharmaceutical industry.
Non-compliance can have significant consequences, making the role of a pharmaceutical tech writer vital in maintaining regulatory standards and ensuring compliance with regulatory submissions.
Documentation includes preparing clinical study reports, standard operating procedures, and test scripts. Here’s the list of duties a pharmaceutical writer is responsible for:
1. Assessing the Creation of Standard Operating Procedures (SOPs)
Tech writers in pharmaceutical companies are primarily responsible for researching how creating, updating, and assessing procedural, and technical documents, which are critical for compliance and safety, influence other technical documentation.
2. Identifying SMEs and Partners
Pharm tech writers work on identifying the subject matter experts for clients and partners. Likewise, they also ensure that SMEs and cross-functional teams take an active part in developing and managing the technical content during the revisions and after approval cycles.
3. Preparing Procedural Documents
Writers in the pharmaceutical industry are responsible for leading the technical writing of medications. Producing error-free instructions is essential to ensure regulatory compliance and safety. It requires collaboration with SME(s) and manufacturing process managers. They translate complex technical information to easy material, process maps.
Likewise, they cross-check the preventive actions, inspection commitments, and process deviations. This collaboration addresses any critical gaps in medicine manufacturing and documentation, ensuring compliance with regulatory requirements and regulatory submissions, regulatory submissions.
4. Overviewing Process Mapping Activities
Pharmaceutical writers collect details of manufacturing processes like boundaries, scopes, process inputs, process outputs, and sequences. They also facilitate these technical process mappings, thus allowing the identification of wastes and bottlenecks.
Through the visualization of data flowcharts, they devise methods to minimize waste and redundancies, enhancing process optimization.
5. Incorporating Reviews into Documentation
Tech writers in the medical industry incorporate the feedback and reviews obtained from higher documentation roles, including document control and quality assurance personnel review. They work on improving the documentation through these reviews and ensure zero redundancy in complex information.
6. Collaborating with Managers
Pharmaceutical company tech writers collaborate with quality managers and regulatory affairs professionals to ensure the content aligns with the company’s SOPs, standards, and Good Manufacturing Practices (GMP). They cross-check the content and ensure that information aligns with the company’s technical writing principles, content standards, and content management systems.
7. Maintaining the Work Schedule
Pharma writers maintain work schedules and project timelines. Tech writers mitigate and identify any risk issues in completing the project procurement.
They also support any process implementations and collaborate with change managers and global training managers for development projects.
8. Preparing Medical User Guides
Just like any other technical writer, pharmacy writers prepare medical reference guides and medical equipment user manuals, enhancing user experience and playing a critical role in the development and validation of production processes of pharmaceutical and medical devices. Manufacturing documentation is critical in ensuring compliance with Good Manufacturing Practices (GMPs), as clear and error-free documentation, including Standard Operating Procedures (SOPs) and batch production records, is essential for maintaining safety and regulatory standards. These duties demand high expertise and medical knowledge, along with strong attention to detail.
9. Preparing Marketing Documents
As the drugs are targeted at consumers and health professionals, a drug writer is responsible for writing the documentation materials and marketing content, ensuring regulatory compliance by keeping in view the audience’s expertise.
In addition to that, for example, a technical writer also writes business presentations and breaks down the complex information into plainer languages to inform health care professionals about the advantages of a certain drug.
Sometimes, a technical writer in the medical device industry also develops website content, newsletters, and other marketing information.
10. Updating their Medical Knowledge
As advancements are crucial, continuing education helps writers and employees in pharmaceutical companies update their medical knowledge to sustain their credibility.
The day-to-day tasks involved can vary, but these are some of the generic duties of pharma technical writers.
What are the Skills of a Pharmaceutical Technical Writer?
A technical writer in the pharmaceutical industry should understand sophisticated pieces of information and technical documentation to convey its plain meaning to a diversified audience. A scientific writer, in particular, must possess strong writing skills to effectively communicate complex scientific information. Here are some skills of a pharmacy tech writer:
Translate complex information into lean and digestible content
Writers adeptly translate complex information into lean, easily digestible pieces of content. They simplify technical jargon and intricate concepts, ensuring the information is clear and accessible to a broad audience.
By breaking down detailed data into manageable sections, they enhance user understanding and engagement, making complex ideas more approachable.
Familiarity with process mapping tools like Microsoft Vision
Professionals familiar with process mapping tools like Microsoft Visio efficiently document and visualize workflows, processes, and systems. They leverage these tools to create clear, detailed diagrams that help teams understand complex processes, identify inefficiencies, and improve overall workflow management.
Good verbal and written language skills
Strong verbal and written language skills enable professionals to communicate effectively in both spoken and written formats. They convey ideas clearly, tailor their communication to different audiences, and ensure that their messages are easily understood, whether through written reports, presentations, or everyday interactions.
Skillful in writing sophisticated processes in an informational and explanatory style.
Writers skilled in crafting sophisticated processes into an informational and explanatory style of text ensure that complex procedures are communicated clearly through well-structured technical documents.
They structure the content logically, using simple language and detailed explanations to guide users through intricate processes without overwhelming them.
Know-how of process improvement and procedural documentation rules
Understanding process improvement and procedural documentation rules allows professionals to document workflows efficiently and identify areas for enhancement. Batch production records are crucial in maintaining compliance and safety, as any errors or unclear steps can lead to severe consequences, including product unusability, client loss, or even patient harm.
They apply best practices in documenting procedures, ensuring that the content is accurate, up-to-date, and aligned with organizational goals for continuous improvement.
Good problem-solving skills
Professionals with strong problem-solving skills quickly identify issues and develop effective solutions. They approach challenges methodically, analyzing the root causes and considering various perspectives before implementing strategies that address the problem at its core.
Collaboration and team-working skills
Effective collaboration and team-working skills are essential for professionals working in diverse, multidisciplinary teams.
They actively contribute to group efforts, communicate openly, and build positive relationships with colleagues to achieve common goals and foster a productive working environment.
Optimal communication skills with diverse departments
Professionals with optimal communication skills engage effectively with diverse departments within an organization.
They understand the unique communication needs of each department, tailoring their approach to ensure that information is shared clearly and efficiently across different teams and disciplines.
Skillful in drafting documentation from provided templates and drafts.
Writers skilled in drafting documentation from provided templates and drafts efficiently produce clear, consistent, and structured documents. Clear and error-free production records are crucial in ensuring compliance with Good Manufacturing Practices (GMPs), preventing negative outcomes such as product unusability and potential harm to patients.
They follow established formats while adapting content to meet specific needs, ensuring that the final product aligns with organizational standards and user requirements.
Familiarity with official drug association rules and regulations
Familiarity with official drug association rules and regulations is crucial for professionals in the pharmaceutical and healthcare industries.
They ensure that all documentation, processes, and communications comply with regulatory standards, including regulatory submissions, minimizing legal risks and maintaining the integrity of products and services in a highly regulated environment.
Employers prefer a BS degree in a related field. According to a pharmacy tech writer’s latest job alert by Simply Hired, 5-6 years of pharmaceutical industry technical writing experience is good, along with a BS degree, while 4 years of experience is appreciable, along with a Master’s degree in the related field.
If you are applying for a technical writing job alert, make sure you meet the organization’s minimum and preferred qualifications and writing skills criteria.
Check out our top-rated technical writing course to master the mandatory technical writing skills. It is a beginner-friendly course that promises exceptional performance and learning outcomes along with the fundamental knowledge required to become an expert technical writer.
What are the Best Practices for Pharmaceutical Technical Writing?
Pharmaceutical writing is challenging as this field requires a continuous update of knowledge to sustain credibility. There are some rules specified for regulatory writing, including regulatory guidelines. Here are the rules:
1. Work on Clarity in Technical Writing
As the pharmaceutical documentation aim for different audiences, it is crucial to write clear and human readable documents in plain language to give clarity and ensure the information serves the purpose for each reader. Avoid words like often, several, few, recently, usually as these words are vague and can interpret different meanings for different readers.
2. Improve Document Design
Document formatting is a crucial step in pharmaceutical documentation. Check whether there are huge chunks of text or not. If any, then divide those chunks into digestible pieces of text.
Make use of various headings and sub-headings and draw attention to text with the use of tables, figures, and visual aids.
3. Be Concise
Conciseness is the level of understanding of the text and information accuracy for the readers. In pharmaceutical writing, the information is crucial and can be fatal if delivered in the wrong way. Focus on the conciseness of text to make the pharmaceutical drugs information crystal clear to both consumers and health professionals. Write in simple and catchable words. Do not present any challenges to the audience and use plain language.
Prevent passive voice and prepositional text. In addition, use an active voice tone to keep the subject always at the beginning of a sentence.
4. Know Your Audience
In pharmaceutical writing, audience identification and audience analysis are the first steps of documentation. Find out whether the audience is drug consumers, health care professionals, or other industries. After that, draft the content by considering the audience’s expertise.
Define highly technical terms, abbreviations, and synonyms at the end goal or start of documentation for easy digestion. Align pharmacy documentation with your company’s content standards. Pay close attention to the accuracy of the content.
Conclusion
Pharmaceutical tech writers are responsible for writing medical user guides, reference guides, and drug-associated manuals, ensuring regulatory compliance.
Normal duties of a pharm tech writer involve the assessment and creation of medical procedural and technical documents, identification of SME(s) and business partners, preparation of procedural documentation, an overview of process mapping activities, and knowing the incorporation of feedback into the work.
Work duties involve collaboration with quality managers, maintaining project consistency, and continuously up-levelling their pharmacy knowledge.
A pharmacy technical writer must follow the company’s SOPs and rules for pharmacy content. They must be skilled in process mapping tools and have good written and verbal communication skills. Many employers appreciate the skills to write complex information into easily digestible pieces of text in the form of reports.
Thus, in many colleges, the requirement is at least a bachelor’s or an applicable master’s degree to become a pharmacy tech writer. It is also necessary to continuously update your writing skills and knowledge.
FAQs
Here are the most frequently asked questions about becoming a pharmaceutical technical writer:
What qualifications are required to become a pharmaceutical technical writer?
To become a pharmaceutical technical writer, a minimum of a bachelor’s degree in a related field, such as biology, chemistry, or pharmaceutical sciences, is typically required. Additionally, 4-6 years of experience in the pharmaceutical industry technical writing is often preferred, with some employers valuing a master’s degree in a related field more than customers.
What types of documents does a pharmaceutical technical writer typically prepare?
A pharmaceutical technical writer is responsible for creating a variety of documents, including medical user guides, reference guides, drug-associated manuals, clinical study reports, standard operating procedures (SOPs), test scripts, and marketing materials for pharmaceutical products.
What skills are essential for a pharmaceutical technical writer?
Essential skills include the ability to translate complex technical information into easily digestible content, proficiency with process mapping tools like Microsoft Visio, strong verbal and written communication skills, knowledge of regulatory guidelines, and, of course, the ability to collaborate effectively with subject matter experts and cross-functional teams.
Why is the role of a pharmaceutical technical writer critical in the industry?
The role is critical because pharmaceutical technical writers ensure that all documentation meets regulatory compliance standards, which is essential for the safety and efficacy of pharmaceutical products. Offering technical writing training can significantly improve documentation quality, ensuring clear and accurate communication. Non-compliance can lead to significant consequences, making accurate and clear documentation vital.
How does a pharmaceutical technical writer stay updated with industry knowledge?
Pharmaceutical technical writers stay updated with industry knowledge through continuous education and training. This involves keeping up with advancements in pharmaceutical sciences, regulatory changes, and best practices in technical writing to maintain their credibility and effectiveness in the role.
If you are new to technical writing and are looking to break in, we recommend taking our Technical Writing Certification Course, where you will learn the fundamentals and importance of being a technical writer, how to dominate technical writer interviews, and how to stand out as a technical writing candidate.
