A pharmaceutical technical writer specializes in creating clear and accurate documentation within the pharmaceutical industry. This role involves medical writing, revising, and editing documents that adhere to regulatory standards and support pharmaceutical product development, manufacturing, and marketing. Key responsibilities include producing clinical trial protocols, standard operating procedures (SOPs), drug submission documentation, regulatory filings, and patient information leaflets.
These writers must understand pharmaceutical terminology, clinical research, FDA regulations, and other compliance requirements. They work with scientists, researchers, regulatory specialists, and healthcare professionals to ensure that all documentation is scientifically accurate and compliant with legal and ethical standards.
According to Glassdoor’s salary estimate, a medical writer earns an average of $82,911 annually. According to different companies, the salary ranges from $52K to $133K, averaging $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 or medical 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 the medical research skills of medical professionals.
Non-compliance can have significant consequences, making the role of a pharmaceutical tech writer vital in proper regulatory medical writing.
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 develop and manage 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 process implementations and collaborate with change and global training managers for development projects.
8. Preparing Medical User Guides
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 essential to 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, medical knowledge, and strong attention to detail.
9. Preparing Marketing Documents
As the drugs target consumers and health professionals, a drug writer is responsible for writing the documentation materials and marketing content, ensuring regulatory compliance by considering the audience’s expertise.
In addition, for example, a technical writer also writes business presentations and breaks down complex information into plainer languages to inform healthcare professionals about the advantages of a particular drug.
Sometimes, a technical writer in the medical device industry also develops website content, newsletters, and other information for the medical writing market.
10. Updating their Medical Knowledge
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 pharmaceutical industry technical writer should understand sophisticated information and technical documentation to convey its plain meaning to a diversified audience. A scientific writer, in particular, must possess strong medical writing skills to communicate complex scientific information effectively. 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 data is clear and accessible to a broad audience.
Breaking down detailed data into manageable sections enhances user understanding and engagement, making complex ideas more approachable.
Familiarity with process mapping tools like Microsoft Vision
Professionals with process mapping tools like Microsoft Visio efficiently document and visualize workflows, processes, and systems. They leverage these tools to create 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 spoken and written formats. They convey ideas clearly, tailor their communication to different audiences, and ensure that their messages are easily understood 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 text style 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 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 practical 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 teamwork 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 ensure compliance with Good Manufacturing Practices (GMPs), preventing adverse outcomes such as product unusability and potential harm to patients.
They follow established formats while adapting content to meet specific needs, ensuring the final product meets 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.
What are the Best Practices for Pharmaceutical Technical Writing?
Pharmaceutical writing is challenging as this field requires updating 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 pharmaceutical documentation aims 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 of each reader. Avoid words like often, several, few, recently, and usually, as these words are vague and can be interpreted differently by 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.
Use various headings and sub-headings and draw attention to text using 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 incorrectly. Focus on the conciseness of the text to make the information about pharmaceutical drugs crystal clear to 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 analysis are the first steps of documentation. Find out whether the audience is drug consumers, healthcare 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.
FAQs
Here are the most frequently asked questions about medical writing.
What is medical writing, and what does a medical writer do?
Medical writing involves creating well-structured, scientifically accurate content for various audiences, including healthcare professionals, regulatory agencies, and the general public. A medical writer translates complex medical science into clear, concise documents such as research papers, clinical trial reports, and regulatory submissions.
How do medical writers ensure accuracy in medical communication?
Medical writers adhere to rigorous research standards, referencing credible sources such as medical journals and clinical studies. They collaborate closely with subject matter experts, including researchers and physicians, to ensure that medical terminology is used correctly and that the medical information is precise and current.
What role do medical journal editors play in medical writing?
Medical journal editors review, refine, and validate the content submitted for publication. They assess the clarity, scientific accuracy, and compliance of medical writing with journal guidelines. A medical writer working with journal editors ensures that manuscripts meet the highest standards for publication.
Why is medical communication important in healthcare and research?
Effective medical communication ensures that scientific findings are accurately conveyed to diverse audiences, including regulatory agencies, healthcare professionals, and patients. Clear and precise communication improves patient care, advances medical science, and supports informed decision-making.
What is the American Medical Writers Association (AMWA), and how does it support medical writers?
The American Medical Writers Association (AMWA) is a professional organization dedicated to advancing excellence in medical writing and communication. It provides resources, training, and certification programs to help medical writers enhance their skills and stay updated on industry standards. AMWA also fosters networking opportunities and professional development for those working in medical science and healthcare communication.
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.
