My services include

  • Conducting scientific literature and regulatory information reviews
  • Crafting reports and CTD section content for regulatory submissions
  • Responding to regulatory intelligence requests ensuring compliance
  • Developing quality management audit and operations documents to streamline operations
  • Preparing and reviewing medical affairs and scientific slide deck presentations with attention to detail
  • Creating engaging white papers and educational content

My writing and consulting are based on interconnected disciplines that play a critical role in producing clear, accurate, and compliant documentation that supports product development, regulatory approval, quality management, and informed decision-making throughout the product lifecycle in regulated industries.

Quality management writing involves creating clear, accurate, and compliant documentation that supports and communicates an organisation's quality assurance (QA) and control (QC) processes. Documents might include quality manuals and standard operating procedures (SOPs).

Regulatory intelligence is the systematic collection and analysis of regulatory information and trends to inform strategic decision-making and ensure compliance throughout the product lifecycle. Documents might include regulatory intelligence reports.

Regulatory strategy is the proactive planning and coordination of regulatory activities to ensure timely product approval and compliance with global health authority requirements throughout the product lifecycle. Regulatory intelligence helps inform regulatory strategy.

Regulatory writing is the process of creating accurate, clear, and compliant documents required by regulatory agencies to support the approval and monitoring of drugs, biologics, or medical devices. Documents might include Common Technical Document (CTD) content.

Scientific writing is the clear, objective, and structured communication of research findings, scientific concepts, or technical information to inform, educate, or persuade a specific audience. Documents might include reviews of literature that inform other types of regulated industry activity.

Technical writing is the practice of creating clear, concise, and structured documents that explain complex technical information to specific audiences, often including manuals, guides, and reports. Documents can feed into quality management systems (QMS).

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Writing

As a skilled writer with an extensive background in life science and biotechnology, my industry experience is in life science sectors related to human and animal health. My support helps company compliance. My help ensures documents meet regulatory standards by presenting complex data in easily understandable formats.

I have a methodical approach to regulatory, scientific, and technical writing.

  1. Source information: My clients provide source information, and using my expertise I can conduct additional regulatory and scientific database searches if needed.
  2. Information review: Based on my source information review and my expertise, I will create a bespoke information appraisal presented in a table considering my client's needs. By doing this, my client can revisit the information appraisal later for in-house purposes.
  3. Outputs for my client's target audience: From the information appraisal I will create a result tailored to my client's target audience. The target audience might include regulatory assessors, people in training, executive management, laboratory teams, academics, or laypeople.
  4. My products: Based on my client’s needs, my products include regulatory intelligence reports, white papers, quality management system (QMS) documents, common technical document (CTD) sections, and slide deck presentations.

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Writing

Consulting and contracting

Consulting defines what needs to be done, while contracting provides the resources and execution to get it done. One overlooked aspect of successful consulting and contracting is the critical role that effective writing plays throughout the engagement process.

Consulting is a powerful tool that allows my clients to leverage my specialised expertise to tackle complex challenges and drive their growth. For my clients, partnering with me as a consultant can provide strategic advantages by offering tailored solutions, an objective viewpoint, and the ability to streamline their business processes.

I apply my key strengths to consulting as much as I do to writing. As a consultant my clear, concise, and persuasive writing is essential for communicating complex ideas, developing actionable plans, and ensuring stakeholder alignment. From the initial partnership agreement to my final product, the ability to write effectively ensures that I convey my findings, recommendations, and strategies in a way that is accessible for my client. Whether crafting a comprehensive report, developing a strategy document, or summarising key insights, writing serves as the bridge between analysis and execution.

I use writing as a tool for clarity and impact which is crucial for my clients. When hiring me as a consultant, you are getting my technical expertise and my ability to communicate clearly and concisely, and if needed, my ability to apply my technical expertise. I document my research, outline strategies, and present ideas that resonate with diverse target audiences at various levels. My ability to craft well-structured reports reflects my ability to organise my thoughts, think critically, and deliver value.

Written communication is key to ensuring that all stakeholders are aligned and engaged when an organisation transforms whether implementing new processes, technologies, or strategies. I use writing to create communications, training materials, and strategic documents that guide teams through change. The clarity of my consulting can directly influence the success of a project and my client’s ability to adapt to new ways of working.

For my clients, the value of my verbal and written communication can help drive regulatory compliance and tangible results.


Key StrengthsProductsMessage Me

Consulting and contracting

Testimonials

What people say about working with me...

... [Jen] has excellent written and verbal communication skills, is extremely organized, works well independently, and shows great individual initiative… Jennifer’s responsibilities were constantly evolving along with the project... [She] helped lead the [project] transition from a proxy based model to one built on the direct input of the researchers. Jennifer always maintained her objectivity and remained focused on a positive outcome for the researchers... [Jen] maintained an excellent rapport with the many constituents served by our project team.

Dennis Barger, VP - General Manager, Fisher BioServices, 2010

Jennifer was really great to work with. She brought huge energy and drive and was delivering results immediately. This required understanding of the science and converting it to industry ready material. She was completely self-motivated, only had to define the objectives and she produced the results time and again. This technical competence, attention to detail and commitment to task make her a great asset to any team.

Brendan Ring, Business Development Manager, Centre for Research on Adaptive Nanostructures and Nanodevices (CRANN), 2010

[Jen] is ... competent, well organized and hard‐working. She is extremely determined and showed good perseverance in overcoming the problems which always arise in scientific research, finding creative solutions and generating many new ideas... [Jen] is capable of both writing and speaking well about science. In personal terms, she is always cheerful, even in the face of setbacks, and interacts well with others...

Chris French, Principal Investigator and Lecturer, University of Edinburgh, 2011

... [Jen is] articulate, very conscientious, highly intelligent and very motivated. She has a strong desire to get to grips with any task that she is given and she was able to complete her tasks to agreed deadlines. She has good interpersonal skills, got on well with everybody, and is a team player. I found Jen to be highly self-motivated and she worked productively under her own initiative requiring little supervision...

Martin Cooney, Financial Director, Renishaw, 2011

... [Jen’s] work predominantly involved review of the clinical evaluation process, and review of clinical papers for products including surgical instrumentation, implants and software. This required her to cover a wide range of technical areas and to interact with a number of project teams. Jennifer addressed these tasks with a high degree of technical competency... She performed well ... being highly self-motivated and able to communicate large amounts of complex information effectively.

Brendan Callinan, Quality Assurance and Regulatory Affairs Manager, Neurological Product Division, Renishaw, 2011

Jen has a lot of relevant knowledge and enthusiasm to learn, which has helped enormously. She is highly motivated, communicative, and efficient at turning around assignments, asking for clarification when necessary and delivering on time.

Janine Jamieson, European Editor, International Pharmaceutical Quality (IPQ), 2022

Jen is great to work with and very passionate about regulatory and writing. We successfully navigated through challenging intel work and impressed the client with our final deliverables.

Cherry Malonzo Marty MD MSc BME, Regulatory Consultant & Medical Writer, 2022

... [Jen is] our “go to” person for jobs outside our formal job descriptions...

Verbal Communication, Biotech Company, 2023

[Jen's] diligent work on various Regulatory Validation and Clinical Review accounts is highly appreciated and recommended by project teams. Projects were always delivered on time and [Jen's] professional comments facilitated the teams' work, and further achieved client satisfaction.

Review Feedback, Global Content Provider, 2024

... [Jennifer] has an exceptional eye for detail, ensuring that every aspect of my work met the highest standards of clarity and precision. Her meticulous approach, combined with her deep understanding of complex scientific concepts, made the entire writing process seamless and enjoyable. Beyond her technical expertise, Jennifer is incredibly easy to work with. She is always approachable, open to feedback, and proactive in finding solutions.

Ahmad Nazzal MD PhD, Medical Writer, 2025

I really enjoyed working with Jen when she was helping to share the CMC regulatory/quality dialogue at International Pharmaceutical Quality (IPQ). She was always great to talk to, suggesting ideas and open to feedback, extremely efficient, punctual, and accurate. I would highly recommend working with her.

Janine Jamieson, European Editor, International Pharmaceutical Quality (IPQ), 2025

I had the pleasure of working with Jennifer on publications for EMWA, where she serves as Associate Editor and Biotechnology Section Editor. She was always professional, providing insightful feedback. Her keen eye for detail and constructive approach made collaborating with her a great experience.

Vanessa Zaiatz Bittencourt, Clinical Research Manager, 2025

Get help for your next compliance or life science writing project

Supporting the product lifecycle from discovery into the marketplace.

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